Much to the chagrin of U.S. gastroenterologists who had praised the European Society of Anesthesiology (ESA) for its rigor and fairness, the society recently decided to retract its endorsement of guidelines for non–anesthesiologist-administered propofol (Pelosi P. Eur J Anaesthesiol 2012;29:208).
“Those of us in the U.S. had applauded the ESA for being more fair-minded and scientifically rigorous than the American Society of Anesthesiologists in their assessment of the published data, and for their willingness to remain objective and avoid conflicts of interest that would jeopardize that objectivity,” said Lawrence B. Cohen, MD, associate clinical professor of medicine, Mount Sinai School of Medicine, in New York City. “Their actions now, which demonstrate that financial self-interest and political influence can trump scientifically valid, evidence-based practice guidelines, reflect poorly on the specialty of anesthesiology and weaken the credibility of the ESA as leaders in the field of sedation and patient safety.”
John Vargo, MD, vice chairman of the Digestive Disease Institute and chairman of the Department of Gastroenterology and Hepatology, Cleveland Clinic, in Ohio, noted that the retraction does seem in keeping with the landscape of propofol-mediated sedation in the United States, but nonetheless he was surprised by the ESA’s reversal of support.
“Perhaps what was the most surprising thing to me was the article by [Azriel] Perel, which questioned whether it was appropriate to adopt strict evidence-based criteria to make these decisions and instead continue to rely on expert opinion [Perel A. Eur J Anaesthesiol 2011;28:580-584].
“We now have nearly 600,000 patients in the literature showing that gastroenterologist-directed propofol, when administered by properly trained personnel in appropriately selected patients, is extremely safe,” Dr. Vargo said. “I really feel this is more of an issue regarding the ‘pharmacoeconomics’ of private practice of sedation in these countries, rather than overall safety issues.”
Ludwig T. Heuss, MD, assistant professor of medicine and director of the medical clinic at Zollikerberg Hospital, in Zurich, Switzerland, deemed the retraction not only ridiculous but scandalous.
“In my view, the ESA gave up their status of a serious scientific society and ended in a selfish, income-guided lobby,” he wrote in an email. “The retraction of the endorsement was enforced against scientific evidence, through a political vote. According to this kind of negation of scientific evidence, I would invite them to decide that the Earth is flat and that the sun is circling around the Earth.”
The guidelines were originally endorsed by the three societies that created them: the ESA, the European Society of Gastrointestinal Endoscopy and the European Society of Gastroenterology Nurses and Associates. The latter two continue to support the original guidelines.
It is not clear whether the ESA’s retraction reflects the opinion of the bulk of anesthesiologists in Europe, where sedation practices and policies vary from country to country. The retraction was made after a little more than half of the members present at the ESA’s General Assembly Meeting last year voted to do so.
“It was not the opinion of the board, but of the present members in the General Assembly, and they were only about 3% of all ESA members or less,” said Eberhard Kochs, MD, chairman, Department of Anesthesia, Klinikum rechts der Isar der Technischen Universität München, in Munich, and president of the ESA. “The board is a little bit uneasy about this, but as a democratic society we have to follow the wish of the General Assembly.”
Dr. Kochs firmly believes the safest practice for the administration of propofol is to restrict its use solely to anesthesiologists, and he strongly disagrees with the suggestion that financial interests were at the heart of the retraction. Motivation for the retraction, however, does appear to be mainly political, he explained. “In some countries of Europe, colleagues fear that sedation will be given by nonspecialists. The problem is that at the moment in several European countries, anesthesiologists do not have enough manpower to do all the sedations in ambulatory and hospital practice. In addition, many health care systems do not reimburse the costs of providing sedation by anesthesiologists outside operating rooms.”
Dr. Kochs does not believe the retraction will have much of an impact on anesthesia practices. “At least right now it will not change anything, because you cannot change a whole system based on some thoughts; you have to fulfill all the criteria, you have to have the manpower,” he said. “This cannot be answered by our side for all of Europe; it is a task for the national societies to organize within their respective countries.”
Dr. Heuss does not anticipate the retraction will have any effect in Switzerland where, according to his 2010 survey, nearly three-fourths of gastroenterologists administer propofol themselves or supervise nurses without anesthesiologist support (Heuss LT. Endoscopy 2012;44:504-511).
“I am convinced the ESA’s retraction will have no impact on our practice in Switzerland, or in Germany, where non–anesthesiologist-administered propofol is also very common,” he wrote. But “the retraction will certainly have implications in other European countries, where the threshold to use screening endoscopy is held artificially high through the additional costs of unnecessary anesthesiologist fees.”
Italy appears to be one of those countries. When the guidelines were originally endorsed by the ESA, Alessandro Repici, MD, the Istituto Clinico Humanitas, in Milan, with support of their anesthesia department, developed a program to train all endoscopists in the administration of propofol and help them obtain advanced cardiac life support certification.
“After a few months, we started gastroenterologist administration of propofol, and in the preliminary analysis of our results in terms of safety and patient satisfaction [it] was extremely positive, with more than 4,000 patients treated,” wrote Dr. Repici, director of that institution’s Digestive Endoscopy Department, in an email. “After the ESA retraction, the board of directors of our hospital has stopped this practice according to advice received by our lawyers and experts in legal medicine.”
At the moment, the ESA, together with the European Board of Anaesthesiologists, is forming a new task force to produce new guidelines for both anesthesiologist-administered- and non–anesthesiologist-administered propofol.
“It should be a guideline on sedation itself, and everyone has to make up his mind whether or not he is competent in doing this,” Dr. Kochs said.