Anesthesia adds risk and cost to the screening procedure, research shows, raising fresh questions about how providers weigh patient satisfaction against outcomes and profit.
New findings on risks associated with the use of anesthesia during colonoscopies and the demise of the first automated sedation device for use in such procedures add sparks to the debate over how sedation should be delivered in the endoscopy suite.
The decision to scrap Sedasys came last month. It had received FDA approval in 2013. Sedasys is a device designed to allow a gastroenterologist, rather than an anesthesiologist, to administer propofol, a powerful drug that offers heavier sedation but faster recovery than the combination of midazolam and fentanyl commonly used by gastroenterologists.
In a statement to HealthLeaders Media last week, Ethicon, the division of Johnson & Johnson that introduced and later withdrew the device, said:
“The Johnson & Johnson Medical Devices Companies are deeply committed to continuing to bring new, meaningful innovation to market that will enhance patient care and improve outcomes. There were no safety concerns that led to Ethicon’s decision to exit the Sedasys business. This was a decision in line with our strategy to prioritize investments in high growth and strategic portfolio opportunities.”
Although some guidelines aim to limit the use of anesthesia service to high-risk colonoscopy patients, the practice has risen significantly in recent years. And while it adds to the cost of the procedure, the practice is not limited to high-risk patients.
The use of anesthesia services for colonoscopy patients rose from approximately 14% in 2003 to more than 30% in 2009 to close to 50% in 2013, according to a series of reports from the Rand Corporation.
A study from the Rand Corporation and the Group Health Research Institute published in April in Gastroenterology, found that the risks of complications were 13% higher for colonoscopy patients who receive anesthesia services than those who do not.
“The widespread adoption of anesthesia services with colonoscopy should be considered within the context of all potential risks,” researchers at University of Washington in Seattle concluded.
Some anesthesiologists warned that the Sedasys device could be dangerous if used off label. But after being turned down once, it won FDA approval and the American Society of Anesthesiologist issued guidelines for its use.
Jeffrey Apfelbaum, MD, the director of anesthesia services at the University of Chicago Medicine, was all set to try the device. He said the company demonstrated the device at the hospital and a group of gastroenterologists and nurses attended company sessions where they were trained on how to use Sedasys.
But Sedasys was pulled from the market before Apfelbaum was able to implement it at his facility.
“Anesthesiologists have a long history of embracing new technology and advances that improve patient care,” he said. “This was the next, natural step in something we needed to explore.”
Apfelbaum did not challenge media reports that business reasons were behind Ethicon’s decision to drop Sedasys, and noted that Sedasys didn’t seem to take off among providers. He observed that “the uptake of the device in the community was extraordinarily slow. ”
And while Apfelbaum expressed hope that the device would improve care, he said he was unsure whether it would be less expensive than anesthesia services. Users were required to buy supplies from Ethicon, the J&J subsidiary that launched the device. It was not clear to Apfelbaum if the savings in anesthesia services would offset the costs of disposable EKG pads and pre-filled propofol cassettes.
Without support from Johnson & Johnson, providers that have been using Sedasys may not be able to continue for long. “Although we have a strong interest in continuing to use Sedasys, we are currently working with representatives of the device manufacturer, Johnson & Johnson, on a plan to phase out its use here at Virginia Mason over the next several months,” said Andrew Ross, MD, section chief for Gastroenterology at Virginia Mason Medical Center.
Anesthesia and Risk
Karen Wernli, PhD, of the Group Health Research Institute in Seattle, WA, is the lead author of the study published in Gastroenterology this month linking the use of anesthesia with an increase in complications during colonoscopies.
She and her team used a large database [more than 3 million colonoscopies nationwide in adults aged 40 to 64] to compare outcomes for patients sedated by anesthesia specialists during colonoscopy to those who were not.
The researchers found that the use of anesthesia services was associated with a 13% increase complication within 30 days, including a higher risk of perforation, bleeding, and abdominal pain. Further, the risk of puncturing the wall of the colon was found to be higher by 26% in those patients who had anesthesia services and at least one polyp removed.
“The fact that there can be somewhat significant downstream consequences, even if they are rare, it is really something to consider,” she said. The paper did acknowledge, that:
Although the use of anesthesia agents can directly impact colonoscopy outcomes, it is not solely the anesthesia agent that could lead to additional complications. In the absence of patient feedback, increased colonic-wall tension from colonoscopy pressure may not be identified by the endoscopist, and, consistent with our results, could lead to increased risks of colonic complications, such as perforation and abdominal pain.
Apfelbaum said he was not surprised by the finding, because doctors performing procedures on deeply sedated patients can work more quickly and a bit more aggressively and would explain the non-life threatening complications.
An editorial accompanying the study said the use of anesthesia “increases patient satisfaction and is profitable to the anesthesia community and some endoscopists, but other outcomes are no better or worse with anesthesia services.”
The editorial argues that the use of “endoscopist-directed propofol is safe but continues to be impeded by legal and regulatory obstacles, local politics and policies and a virtual absence of financial incentives.”
Donald Arnold, MD, chair of the American Society of Anesthesiologists‘ committee on quality management, said in a written statement that endoscopists “do prefer to have their patients as comfortable as possible during procedures and also be able to focus exclusively on performance of endoscopic procedures which entail unique risks. These goals have led endoscopists to increasingly request use of sedation/anesthesia techniques which requires involvement of physician anesthesiologists and other anesthesia professionals.”