Two new choices in endoscopy sedation that theoretically could remove anesthesia providers from the GI suite inched closer to FDA approval last month. The news of these pending product releases sparked discussions over their future application in cost-conscious and safety-minded endoscopy centers. Here's a review.
- Sedasys. Ethicon's Sedasys System is computer-assisted sedation, integrating drug delivery and patient monitoring. Sedasys fared well in a company-sponsored study that showed gastroenterologists and nurses used the automated device for safe and effective propofol administration. According to the Ethicon study, patients who received propofol sedation with the Sedasys System experienced fewer and less significant oxygen desaturation events and recovered twice as fast as patients sedated with midazolam plus fentanyl or meperidine. Ethicon says the Sedasys System integrates drug delivery and patient monitoring by automatically detecting and responding to signs of oversedation by stopping or reducing the delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The system monitors and records six patient parameters: oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.
- Aquavan. This propofol variant releases propofol, the world's leading intravenous sedative-hypnotic agent, when hydrolyzed. An FDA advisory board recommended Eisai's Aquavan (fospropofol disodium) for approval, but qualified the ruling by voting against Aquavan's use by non-anesthesia providers. Aquavan is converted to propofol after injection. That conversion minimizes the drug's initial concentration in the bloodstream, creating a gradual increase in the patient's depth of sedation and a safer alternative to propofol's rapid onset, according to Mary Lynne Hedley, PhD, executive vice president of Eisai Corporation of North America, Aquavan's U.S. marketer. Dr. Hedley believes Aquavan's gradual onset and the company's clinical trials support the drug's use by non-anesthesia providers, despite the FDA advisory committee's ruling.
???All about the money'
As the FDA reviews the Sedasys System and Aquavan, specialties that constantly toe the line between financial solvency and patient safety have begun posturing over the future of the new sedation options. It's important to understand the driving force behind the development of a device and drug that claim to eliminate the need for trained anesthesia providers, says Jeff Mandel, MD, clinical associate professor of anesthesiology and critical care at the University of Pennsylvania School of Medicine in Philadelphia.
"It's all about money," he says, in reference to the current economic reality: Endoscopy reimbursements are decreasing and expenses remain constant. Aetna even recently announced plans to stop underwriting monitored anesthesia care for diagnostic procedures, before eventually backing off the policy change at least until the FDA approves alternatives to anesthesiologist-monitored sedation services. An Aetna spokeswoman confirmed the insurer is monitoring the pending approvals of the Sedasys System and Aquavan.
The American Society of Anesthesiologists reacted strongly to Aetna's possible reimbursement change, stating the elimination of anesthesia payments may "induce some providers to provide depths of sedation for which they are unqualified and thereby compromise the safety of patients undergoing endoscopy." The American Gastroenterological Association also expressed its concerns, claiming that "anesthesiologists are necessary for patients who need deep sedation with propofol, but whose gastroenterologists aren't trained to administer deep sedation."
Any endoscopy center's administrator would be interested in improving financial performance in light of today's economic landscape, says Chris Fromme, administrator at Heritage Park Surgery Center in Sherman, Texas. "But taking the CRNA or anesthesiologist out of the care equation puts the burden of airway management back on the physician and nursing staff," he says, predicting a mixed reaction among gastroenterologists. "Some of the more aggressive docs will be happy to take on that added responsibility, while others will want a trained anesthesia provider present during cases."
The Sedasys System is good in theory, but dangerous in practice, says Mark Green, CRNA, MSN, president of Green's Anesthesia Service in Springfield, Vt. "You can't automate anesthesia delivery to patients who vary in body composition, particularly in the airway," he cautions. "What happens if something goes wrong? Can we automate rescuing the airway?"
Mr. Green notes that Aquavan differs from propofol only out of the bottle. "You need someone trained in general anesthesia to deliver the drug," he says. "Propofol in small amounts works well, but the line between sedation and general anesthesia can be easily crossed, and the problem is, no one knows where that line is."
As evidenced by the still-unresolved debate over the proper administration of propofol, the economics of GI is a complicated issue, says Dr. Mandel. "Right now, specialty groups are focused on a very narrow aspect of care, based on their own economic interests," he says. "All involved parties can prevent an awful lot of colon cancer deaths by focusing on getting screening compliance to three times what it is now. That might be lost in all this talk."