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The rise, fall, and future direction of computer-assisted personalized sedation

Martin, James F.a; Niklewski, Paul J.a,b; White, Jeffrey D.c

Current Opinion in Anesthesiology: August 2019 - Volume 32 - Issue 4 - p 480–487
doi: 10.1097/ACO.0000000000000761
DRUGS IN ANESTHESIA: Edited by Ken B. Johnson
Free

Purpose of review The first computer-assisted personalized sedation (CAPS) device was developed to address the growing demand for routine endoscopy procedures in the United States in the early 2000s. This review will describe the environment that gave rise to CAPS and summarize the design of that first device. It will then discuss the market forces that led to the fall of CAPS, with sales of the device ending 2 years after commercialization.

Recent findings CAPS was initially conceived as a means to enable proceduralists to administer conscious sedation with propofol safely. In the nearly 20 years since its conception, the expectations of patients and proceduralists for endoscopy sedation, have evolved from conscious sedation to deep. Due to the increased risk inherent in deep sedation, future CAPS devices should be tools for anesthesiologists, not proceduralists.

Summary Over $2 billion are spent annually for anesthesia services in routine endoscopic procedures for low-risk patients; a spending rate that is not sustainable. CAPS, in an ‘anesthesia oversight’ model similar to medical supervision, has a future as a cost-efficient means for anesthesia services to provide sedation in endoscopy and other nonoperating room venues. Anesthesiologists should work with medical device companies and payers to develop a CAPS ‘anesthesia oversight’ model.

aMDP-Solutions, LLC

bDepartment of Pharmacology and Systems Physiology, College of Medicine, University of Cincinnati, Cincinnati, Ohio

cDepartment of Anesthesiology, University of Florida, Gainesville, Florida, USA

Correspondence to Paul J. Niklewski, PhD, CARE/Crawley Building, Suite E-870 3230, Eden Avenue, Cincinnati, OH 45267, USA. Tel: +1 513 558 7333; e-mail: niklewpj@ucmail.uc.edu

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INTRODUCTION

Clayton Christensen is credited with the theory of disruptive innovation [1]. Here follows the historical account of a device that fits the definition of disruptive innovation: created to fill a need in the anesthesia forum, with the intention of making a positive impact on the delivery of healthcare. It is recounted from the unique perspective of two individuals (J.M. and P.N.) who were integral to the company that created the Sedasys System (Sedasys). As the Clayton Christensen Institute states, ‘…disruption is a positive force. Disruptive Innovations are NOT breakthrough technologies that make good products better; rather they are innovations that make products and services more accessible and affordable, thereby making them available to a larger population’ [2]. Although the account of Sedasys, the first computer-assisted personalized sedation (CAPS) device, ends with the product being withdrawn from the market, CAPS seems inevitable, as anesthesia resources are limited and in increasing demand.

Box 1

Box 1

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THE RISE OF COMPUTER-ASSISTED PERSONALIZED SEDATION

The goals of sedation, an integral part of the majority of gastrointestinal endoscopic procedures performed in the United States, are to improve patient experience by reducing pain and anxiety [3] and to improve outcome measures, such as cecal intubation rate [4]. These ultimately lead to better adherence to recommended screenings and follow-up [3]. At the turn of the 21st century, sedation was primarily endoscopist-directed, targeting minimal-to-moderate sedation (conscious sedation) using a combination of midazolam and an opioid [5]. Anesthesia professionals providing sedation were typically reserved for high-risk patients [American Society of Anesthesia (ASA) Class 3 or 4], or those requiring deep sedation under monitored anesthesia care (MAC). In 2001, approximately 11% of screening colonoscopies involved an anesthesia professional [6,7].

In the early 2000s, the number of routine endoscopy procedures performed was growing substantially, because of an aging population, increased awareness of the benefits of cancer screening, and revised reimbursement policies for colonoscopy [8,9]. The demand for procedures exceeded the ability of endoscopists to timely screen patients and wait times of 3–6 months were not uncommon [10]. One method of reducing the growing backlog in screening was to improve practice efficiency [11]. Propofol, with its rapid onset and short context-sensitive half-life, offered the solution by reducing discharge and case turnover times.

At that time there was a relative shortage of anesthesiologists and nurse anesthetists in the United States [12,13]. This gave rise to US endoscopists directing propofol delivery through nurse-administered propofol sedation (NAPS) [14,15]. For context, nonanesthesiologist-administered propofol for endoscopy sedation is common outside the United States [16,17], whereas unsedated endoscopy is considered standard of care [18]. However, propofol-labeling specifies administration of propofol only ‘by persons trained in the administration of general anesthesia’ [19]. The practice of NAPS in the United States diminished after FDA denied the American College of Gastroenterology's petition to delete this specification from propofol's label [20].

Concurrent with the rise of NAPS, Ethicon, a Johnson & Johnson company (Cincinnati, Ohio, USA) began the development of Sedasys. The concept for Sedasys was conceived by an anesthesiologist in 2001, and the company enlisted a panel of anesthesiologists to provide expert advice throughout its development. The panel consisted of international experts in the pharmacology of sedatives and analgesics, target-controlled infusion, and anesthesia-monitoring equipment. Between 2003 and 2009, the panel met eight times to critically review Sedasys’ drug delivery algorithms, patient monitoring, human factors, and clinical study design and results.

The objective of Sedasys was to enable endoscopist/nurse teams to safely administer propofol during routine endoscopic procedures, by integrating propofol delivery with patient monitoring. The dosing algorithm in Sedasys was derived from pharmacokinetic principles and recommendations in the FDA-approved propofol label [19], and designed to provide minimal-to-moderate sedation (Table 1). The behavior of the propofol-dosing algorithm is similar to target-controlled infusion (TCI), but instead of entering a targeted effect-site concentration (ESC), the user selects an infusion rate targeted to maintain moderate sedation. As with TCI, Sedasys will deliver a loading dose upon the initiation of sedation to rapidly achieve the targeted level of sedation, with the loading dose proportional to the selected infusion rate.

Table 1

Table 1

With TCI, if the selected ESC does not achieve the desired level of sedation, the user selects a new ESC. To rapidly achieve the targeted level of sedation, if the ESC was increased TCI will deliver an incremental loading dose, and if the ESC was decreased TCI will briefly pause the infusion. With Sedasys, if the selected maintenance rate does not achieve the desired level of sedation, the user selects a new maintenance rate, and similar to TCI, Sedasys will deliver a loading dose or pause the infusion, depending on if the maintenance rate was increased or decreased, before delivering propofol at the selected maintenance rate.

Sedasys contained a comprehensive monitoring suite [21▪] that included pulse oximetry, capnometry, electrocardiogram, and noninvasive blood pressure in accordance with the monitoring recommendations in the ASA ‘Practice Guidelines for Sedation and Analgesia by Nonanesthesiologists’ (Guidelines) [22], and an automated responsive monitor (ARM) [23]. By prompting the individual patient for a response, via tactile and auditory stimulus, ARM accounted for propofol's interpatient variability and narrow therapeutic window and provided the user an objective assessment of the patient's sedation level.

Additional functionality of Sedasys (Table 2) included responsive oxygen delivery, whereby supplemental oxygen was delivered via oral-nasal cannula at a baseline rate of 2 L/min [21▪], and the integration of patient monitoring with propofol delivery [21▪]. It is important to note that although the system did incorporate feedback from the monitoring suite, Sedasys was not a closed-loop sedation system.

Table 2

Table 2

The clinical program for Sedasys consisted of 14 clinical studies, culminating in a 1000-patient, multicenter, randomized controlled study [24▪]. The study's primary endpoint was a newly defined measure of patient safety, designated as the area-under-the-curve of oxygen desaturation (AUCDesat). This new index integrated the incidence, depth, and duration of all oxygen desaturation events occurring during the procedure [25]. Patients in the Sedasys group had a significantly lower mean AUCDesat (23.6 s·%) compared with the midazolam/opioid control group (88.0 s·%; P = 0.028). [24▪].

The study's secondary endpoints included the level of sedation as assessed with the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score and patient satisfaction as measured by the Patient Satisfaction with Sedation Instrument (PSSI) [26]. Patients were predominately minimally-to-moderately sedated in both treatment groups (Fig. 1), and patients sedated with Sedasys were significantly more satisfied than patients in the control group (P = 0.007) [24▪]. The mean total propofol dose in this study was 106 ± 57 mg for colonoscopy and 70 ± 37 for esophagogastroduodenoscopy (mean maintenance infusion rates of 48 ± 13 and 54 ± 15 μg/kg/min, respectively) [24▪].

FIGURE 1

FIGURE 1

In May of 2009, as part of the Pre-Market Approval pathway, FDA took Sedasys to its Anesthesiology and Respiratory Therapy Devices Panel (Advisory Panel). After weighing its intended use, design and the sum of the clinical data, the Advisory Panel voted 8 to 2 for approval of Sedasys, for the following indication:

Intravenous administration of propofol for the initiation and maintenance of minimal-to-moderate sedation in ASA physical status I and II adults undergoing colonoscopy and EGD procedures without the requirement that users need to be ‘trained in the administration of general anesthesia’[27].

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THE FALL OF COMPUTER-ASSISTED PERSONALIZED SEDATION

The fall of CAPS started before FDA's Advisory Panel voted for approval of Sedasys. Although FDA-approved Sedasys, it was not until 4 years after the Panel's vote for approval. FDA first issued a Not Approvable Letter in 2010, and subsequently issued an Approvable Letter in 2012, 2 years after Ethicon appealed the Not Approvable Decision [28–30]. A Condition of Approval was the development of a training program in minimal-to-moderate sedation, including propofol, for users of the system. After Ethicon worked with the International Society for Anaesthetic Pharmacology to develop a training program, FDA issued an Approval Letter in 2013 [31]. Sedasys was approved in 2013 with the same design and the same clinical data that was available in 2009. As no design changes or data were generated, it begs the question, why was it not approvable in 2009 with the same Conditions of Approval, specifically the development of the training program?

The answer can be found in the anesthesia community's reaction to this disruptive innovation. The ASA and many of its membership had strong reservations and concerns about Sedasys. ASA representatives spoke out against approval of Sedasys at the FDA Advisory Panel in 2009 [32▪▪]. They did this without first-hand knowledge of the system or the full set of clinical data supporting its safety and effectiveness. Additionally, Congressional lobbying reports [33] show that Sedasys was a frequent topic of ASA's lobbying efforts from 2008 through device approval in 2013. Ethicon reached out to ASA leadership several times during the development of Sedasys, to share information about the system; but each offer was declined. It was only after FDA approved Sedasys that ASA leadership agreed to meet with the company (personal knowledge of J.M. and P.N.).

Furthermore, individual anesthesiologists with no first-hand knowledge of Sedasys voiced their opinions in opposition to Sedasys in forums, such as the ‘point-counterpoint’ sessions at ASA annual meetings and internet blogposts [34,35]. Many of these opinions contained inaccurate information regarding the design of Sedasys or ran counter to the recommendations in the ASA Guidelines [22]. For example, it was stated that the oxygen delivered by the system would delay recognition of hypoventilation or an obstructed airway by pulse oximetry, which is physiologically accurate, yet irrelevant because Sedasys’ monitoring suite included capnometry. The addition of capnometry monitoring would not only detect hypoventilation or an obstructed airway, but was also fully compliant with the ASA's Guidelines for basic monitoring during sedation [22].

These opinions also contained inaccurate information about the pivotal clinical study. Prior statements that oxygen delivery would mask adverse conditions, such as hypoventilation, were ignored and it was said the study was biased in favor of Sedasys because more oxygen was delivered by the system, than in the control group. In fact, baseline oxygen at 2 L/min was required for the study's control group, and the total oxygen delivered was similar in both groups [36▪▪]. Despite ignoring the presence of capnometry when describing risks of oxygen delivery by the system, it was said the study was biased because capnometry was not used in the control group. In fact, including capnometry in the control group would have biased the study against Sedasys. At the time, capnometry was not part of the standard of care for endoscopist/nurse administered sedation, and Sedasys was bringing that important patient monitor to the practice.

None of those expressing contrary opinions cared to mention that FDA's Advisory Panel had considered all these issues [32▪▪,36▪▪] in their review of the design, the clinical data, and the intended use of the system, before voting 8 to 2 for approval of Sedasys. Further, these opinions were quickly echoed by others, and soon these factually inaccurate opinions appeared in peer-reviewed publications. As late as 2014, a year after Sedasys was approved, these opinions continued regardless of dissemination of the data and design [37].

Given that the anesthesia community had established a rich history of being early adopters of new technology, especially when such technology demonstrated improvements in patient safety, the actions of the ASA and some vocal anesthesiologists in response to Sedasys was unfortunate. There was a misimpression that CAPS was launched to outperform, or even to replace, anesthesia professionals working within the endoscopy suite [38]. One prevalent argument, illustrated within an editorial article, was that the pivotal clinical study was flawed as it did not compare Sedasys to anesthesia professionals [37]. Sedasys was never intended to replace anesthesiologists. Instead, it was intended to replace the practice of sedation with midazolam and an opioid by an endoscopist/nurse team, which was the standard of care in the early 2000s when development began [5], and this fact was recognized in that same editorial [37].

When Sedasys was finally approved, it could not be commercialized immediately. During the 4 years in which Ethicon was appealing FDA's decision not to approve Sedasys, the company minimized investment in the system; not knowing if it would get approval (personal knowledge of J.M. and P.N.). Over that time period, several components of the system became obsolete. After Sedasys was approved, the company had to replace the obsolete components, reverify the system, and seek FDA approval for the replacements. As a result, Sedasys was not commercialized until October 2014 [39].

By 2014, when Sedasys was commercialized, the sedation landscape had changed dramatically. As shown in Fig. 2, the presence of anesthesia professionals in routine endoscopy procedures showed dramatic growth, from minor penetration in 2000 (top left) to approximately 50% penetration in 2014 (bottom right). Although economic incentives may have played a dominant role in this initially, the increasing administration of MAC sedation by anesthesia professionals was changing the expectation of patients and endoscopist; both were beginning to expect deep sedation. The Veterans Administration (VA) hospital system, a capitated model of healthcare, saw more than a doubling in the rate of MAC used for outpatient endoscopies between 2000 and 2013, with an especially noticeable upswing between 2008 and 2013 [40▪]. In 2014, the Centers for Medicare & Medical Services waived cost sharing for anesthesia services during screening colonoscopy, in the recognition that use of anesthesia services had become standard practice [41].

FIGURE 2

FIGURE 2

In the early 2000s, when development of Sedasys started, the expectation of both patients and endoscopists was minimal-to-moderate sedation, yet by the time the system was commercialized, it had become deep sedation. Sedasys was designed for the safe administration of minimal-to-moderate sedation and could not meet the new expectations of the endoscopy market. The company stopped distribution of the system in 2016 [42], and with that, CAPS as a tool to enable nonanesthesia professionals to administer minimal-to-moderate sedation with propofol was no longer viable. As one United States anesthesiologist conjectured: ‘the idea of mild-to-moderate sedation is dead on arrival’ [38] (p. 687).

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FUTURE DIRECTION FOR COMPUTER-ASSISTED PERSONALIZED SEDATION

The significant increase in anesthesia professionals providing MAC sedation in routine endoscopy procedures has a significant impact on healthcare spending in the United States. Between 2003 and 2009, the annual spending for anesthesia services in endoscopy more than tripled, increasing from $0.4 billion to $1.3 billion, of which $1.1 billion was for sedation of low risk patients [43]. Through 2013 the annual spending for anesthesia services in these procedures continued to increase, with $1.5 billion spent on sedation of low-risk patients [44▪]. Extrapolating these numbers to 2019, $2.1 billion will be spent on anesthesia services in endoscopy this year for the sedation of low-risk patients.

Recently, the American Cancer Society has lowered their recommended age for colorectal screening from 50 to 45 years old [45], noting that colon cancers in young people (some as young as their early 20s) have been detected at an increasing rate [46] and that many of these patients present with metastatic disease. This recommendation affects an additional 22 million Americans per year [47], and could potentially result in an additional $1 billion being spent on anesthesia services in endoscopy annually.

This rate of spending is not sustainable, and new models for the administration of sedation in endoscopy procedures need to be developed. There remain advocates for NAPS [48–50], but now that deep sedation is the expectation for both patients and endoscopists in the United States, is NAPS a realistic or well tolerated alternative? Historically, 67% of United States endoscopists cited medicolegal concerns as the primary cause for their reluctance to adopt NAPS [51]. Propofol labeling still requires users to be ‘trained in the administration of general anesthesia’ and it is unlikely that FDA will remove or modify that warning.

With the current expectation for deep sedation, it is equally unlikely that CAPS will return as a tool for endoscopist/nurse teams to administer propofol for minimal-to-moderate sedation. Future CAPS systems would have to target deep sedation [38,52]. It is the authors’ opinions that, given the challenges encountered getting FDA approval of Sedasys for minimal-to-moderate sedation, it is unreasonable to assume FDA would approve a CAPS system for the administration of deep sedation by nonanesthesia professionals. However, a CAPS system approved by FDA for use only by ‘persons trained in the administration of general anesthesia,’ would not address the burdensome costs to the healthcare system, but rather add to those costs.

For CAPS to have a future, it must provide a solution that addresses the expectations of patients and endoscopists. If propofol remains integral to the sedation algorithm, then the next iteration of CAPS will need to be sufficiently aligned with the propofol label to receive FDA approval. To achieve successful market penetration, future CAPS iterations should early on involve anesthesiologists and the ASA [37], and be able to demonstrate a reduction in the current costs associated with sedation in endoscopy procedures. A potential solution is an ‘anesthesia oversight’ model, which could involve:

  1. a FDA-approved CAPS system capable of targeting deep sedation
  2. dedicated sedation nurses, within the department of anesthesiology, trained to administer deep sedation with CAPS
  3. a reimbursement model, similar to medical supervision (as opposed to medical direction), in which one anesthesiologist oversees multiple sedation nurses administering sedation with the CAPS system.

The CAPS system could be similar to Sedasys, with the dosing algorithms adjusted for deep sedation and the automated responsiveness monitor replaced with a depth of sedation monitor that can detect the transition to general anesthesia, such as the Bispectral Index (Medtronic, Boulder, Colorado, USA) or NeuroSENSE (NeuroWave Systems, Inc, Cleveland Ohio, USA). Or the CAPS system could become a closed-loop sedation delivery system, like the AutoSED under development by NeuroWave Systems, Inc. (Cleveland, Ohio, USA) [53].

Requiring that the nurse who is administering sedation with the CAPS system be a member of the anesthesiology department, rather than gastroenterology, ensures the nurse will have the appropriate training and requisite knowledge of airway rescue techniques to safely administer deep sedation with CAPS. It also guarantees that the nurse administering deep sedation is not involved in the conduct of the endoscopy procedure, which is a specification in the propofol label [19].

The anesthesiologist overseeing the administration of sedation via CAPS would be responsible for patient assessment and development of the sedation plan (which could include specifying the initial propofol infusion rate, maximum infusion rates, and alarm adjustments), and would remain immediately available to assist if needed. As with medical supervision and medical direction, the ASA could establish the appropriate ratio of anesthesiologist to nurses that ensures safety in the oversight model.

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CONCLUSION

Sedasys, the first and only CAPS device, was designed to provide minimal and moderate sedation, the standard of care for routine endoscopy when its development started. Throughout its development and regulatory approval (12 years), the expectation of patients and endoscopists had evolved to deep sedation. Sedasys was neither designed, nor approved, to provide deep sedation, therefore, its commercial success was limited. However, there is perhaps an even greater need for CAPS now, because of an increasing demand for anesthesia services, patient expectations for deep sedation, and continued scrutiny of spending in healthcare. CAPS, if designed for deep sedation under an ‘anesthesia oversight’ model could be a cost-effective mechanism to safely deliver on patient and clinician satisfaction, not just in the endoscopy suite, but in other nonoperating room venues where anesthesia services are increasingly responsible for sedation. For this vision to be realized, anesthesiologists must work with medical device companies to develop CAPS systems capable of providing deep sedation as well as with proceduralists and payors to develop reimbursement models for ‘anesthesia oversight’.

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Acknowledgements

We would like to thank Mary E. Edwards for her literature search through the PubMed database to find relevant publications.

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Financial support and sponsorship

None.

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Conflicts of interest

J.M. was the Executive Director of Clinical, Medical and Scientific Affairs at Ethicon, a J&J Company, during the development of the Sedasys System. P.N. was a Principal Scientist at Ethicon. J.W. has no conflicts to declare.

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REFERENCES AND RECOMMENDED READING

Papers of particular interest, published within the annual period of review, have been highlighted as:

  • ▪ of special interest
  • ▪▪ of outstanding interest
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REFERENCES

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This reference describes the functions and operation of the Sedasys System, the first and only CAPS device brought to market. Given the plethora of inaccurate material published in peer-referenced anesthesia literature, and on blogs, the reader is encouraged to refer to this document.

22. American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002; 96:1004–1017.
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This article summarizes the pivotal clinical study of the Sedasys System. It enrolled 1000 ASA Class I to three patients in a multicenter randomized comparative study of Sedasys versus the current standard of care sedation for routine endoscopy. Readers are encouraged to review this for themselves to gain perspective on the ensuing public commentary that quoted (or misquoted) the study's design and findings.

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This reference makes for interesting reading, since it is an official transcript of the FDA Medical Devices Advisory Committee hearing to consider whether to approve the Sedasys System. Opposing arguments and opinions are laid out, from which the reader can both gain insight into the workings of FDA approval, and understand better the challenges of bringing an innovative medical device to market.

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The briefing material provided by Ethicon to FDA's Anesthesiology and Respiratory Therapy Devices Panel prior to the May 2009 Panel meeting. Readers are encouraged to review this for themselves, as it provides substantially more analysis of the pivotal clinical study data than what could be provided in a peer-reviewed publication.

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Notable for its analysis of increased anesthesia services in a capitated integrated health system (VA hospitals). It details patient-level, provider-level and facility-level factors contributing to the rise in the use of MAC deep sedation by 17% per fiscal year, and overall a seven-fold increase over the study period.

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Notable for its analysis of increased anesthesia services in both Medicare and commercially insured patients. It shows the growth in regional penetration of anesthesia services in routine endoscopy, the proportion of these services provided in routine endoscopy procedures, and the overall spending for these services in the United States.

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Keywords:

automated sedation; computer-assisted personalized sedation; nurse-administered propofol sedation; Sedasys System; target-controlled infusion

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