Gastroenterology
Volume 138, Issue 5 , Pages 2022-2024, May 2010

Reply

Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Clarian Health Partners, Indianapolis, Indiana

published online 22 March 2010.

Article Outline

 

We described the safety of Endoscopist Directed Propofol (EDP) administration in 646,080 cases from 28 centers.1 EDP refers to the administration of propofol by a nurse or other mid-level provider under the direct supervision of the endoscopist performing an endoscopic procedure.

Drs Jacobs and Vila state that our data were “predominantly research-derived databases and academic centers.” Both contentions are incorrect. All but 1 of the centers collected their data prospectively for the purpose of documenting their safety experience during routine clinical practice. In many instances, this was done so that they could demonstrate the safety of their practice to a local institutional sedation committee and/or anesthesiologists. Only 4 of the 17 US centers contributing to the previously unpublished data were academic medical centers; collectively, they contributed <10% of the 422,424 cases.1 Thus, contrary to Drs Jacobs and Vila's contention, most of the published experience with EDP has been accumulated by community gastroenterologists. The use of EDP by community gastroenterologists has become commonplace in community practices in Switzerland2 and Germany,3, 4, 5, 6 and (as I have recently learned) in the state of Utah (Peder Pederson, personal communication), in all cases with excellent safety records.

Drs Jacobs and Vila contend that the EDP experience is based on settings where the sedation is given by an academic attending and the procedure performed by a fellow, or vice versa. An e-mail survey of the co-authors of our paper identified 4 centers (2 in the United States and 2 in Europe) where that model was used at least part of the time. In the community practices, there are no fellows. In most centers, propofol was administered by a registered nurse who also monitors the patient and is supervised by the attending physician, but the attending physician's primary focus is performing the procedure or supervising the fellow performing the procedure. There is no convincing evidence that use of an anesthesiologist is associated with improved adenoma detection. Indeed, the highest adenoma detection rates ever reported during colonoscopy were by an endoscopist using EDP.7, 8

To my knowledge, none of the cases of death in Florida with propofol involved EDP. The occurrence of deaths in surgery offices in Florida does not diminish the remarkable safety record of EDP, although it does emphasize the need for endoscopists planning to start EDP to get appropriate training.9

The concept and definition of deep sedation was invented by the American Society of Anesthesiology and has never been validated. In fact, deep sedation initially was considered to be an acceptable target for nonanesthesiologists,10 and became the exclusive domain of anesthesiologists only recently (2006) when the American Society of Anesthesiology House of Delegates issued a 1-sentence statement to that effect (without any accompanying reference).11 Endoscopists have a long track record of safely using both opioids and benzodiazepines as well as propofol to achieve either deep1, 12, 13 or moderate1, 12, 14 sedation.

Drs Jacobs and Vila also claim to have no conflicts of interest. Such a statement is clearly misleading, if not a blatant distortion of the truth, because they have a personal financial interest in defending the anesthesiologist's role in endoscopic sedation. Indeed, it is time for anesthesiologists to declare their obvious and very large conflict of interest when commenting on the practice of EDP. Similarly, gastroenterologists who are profiting from their association with anesthesia specialists should also acknowledge their financial conflict of interest. Consequently, the debate over EDP pits the practitioners of EDP, with no personal or professional conflict of interest (there is no separate fee for EDP) and supported by a large body of scientific evidence indicating the safety of this practice, against anesthesia specialists and others who stand to profit very handsomely from maintaining the status quo. We are in a health care cost crisis where numerous calls have been made to base health care decisions on value.15, 16 Each specialty has an obligation to identify areas of practice that are of questionable value and not supported by evidence.17 Anesthesia specialist involvement in routine endoscopic procedures is adding billions of dollars per year to our health care bill with no proven value.1

On December 11, 2009, the Center for Medicare and Medicaid Services (CMS) issued a policy, without any public comment period, stating that propofol must be administered in hospitals by an anesthesia specialist or a trained MD or DO who is not performing the medical procedure.18 This policy effectively ends, for now, the administration of propofol by trained registered nurses supervised by endoscopists in the United States. CMS officials have indicated that this decision was based solely on the 20-year-old propofol package insert. CMS did not issue any report or discussion of published evidence on EDP or of the cost implications of converting to a model of anesthesiologist-delivered propofol for endoscopy. The CMS also indicated that under its policy, propofol can be titrated even to moderate sedation only by the individuals described above. Thus, CMS has adopted a position that is even more radical than that of Drs Jacobs and Vila, who state they would not oppose EDP targeted to moderate sedation. We would appreciate if Drs Jacobs and Vila would contact CMS and explain their position in this regard.

We expect EDP to continue and grow outside the United States, and look forward to when those who make health care policy in the United States routinely consider available medical evidence, and give due consideration to whether health care services provide value commensurate with their cost.

Back to Article Outline

References 

  1. Rex D, Deenadayalu VP, Eid E, et al. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology. 2009;137:1129–1137
  2. Heuss LT, Froehlich F, Beglinger C. Changing patterns of sedation and monitoring practice during endoscopy: results of a nationwide survey in Switzerland. Endoscopy. 2005;37:161–166
  3. Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomized, controlled study. Am J Gastroenterol. 2005;100:1957–1963
  4. Wehrmann T, Grotkamp J, Stergiou N, et al. Electroencephalogram monitoring facilitates sedation with propofol for routine ERCP: a randomized, controlled trial. Gastrointest Endosc. 2002;56:817–824
  5. Wehrmann T, Kokabpick S, Lembcke B, et al. Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study. Gastrointest Endosc. 1999;49:677–683
  6. Riphaus A, Wehrmann T, Weber B, et al. S3 Guideline: sedation for gastrointestinal endoscopy 2008. Endoscopy. 2009;41:787–815
  7. Rex DK, Helbig CC. High yields of small and flat adenomas with high-definition colonoscopes using either white light or narrow band imaging. Gastroenterology. 2007;133:42–47
  8. Kahi C, Anderson JC, Waxman I, et al. High-definition chromocolonoscopy vs. high-definition white light colonoscopy for average-risk colorectal cancer screening. Am J Gastroenterol. 2010 Feb 23;[Epub ahead of print]
  9. Vargo JJ, Cohen LB, Rex DK, et al. Position statement: nonanesthesiologist administration of propofol for GI endoscopy. Gastroenterology. 2009;137:2161–2167
  10. 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
  11. Statement on Granting Privileges to Non Anesthesiologist Practitioners for Personally Administering Deep Sedation or Supervising Deep Sedation by Individuals who are not Anesthesia Professionals. www.asahq.org/publicationsAndServices/standards/39.pdfAccessed January 8, 2009
  12. Patel S, Vargo JJ, Khandwala F, et al. Deep sedation occurs frequently during elective endoscopy with meperidine and midazolam. Am J Gastroenterol. 2005;100:2689–2695
  13. VanNatta ME, Rex DK. Propofol alone titrated to deep sedation versus propofol in combination with opioids and/or benzodiazepines and titrated to moderate sedation for colonoscopy. Am J Gastroenterol. 2006;101:2209–2217
  14. Cohen LB, Hightower CD, Wood DA, et al. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004;59:795–803
  15. Orkin F, Duncan PG. Substrate for Healthcare Reform: anesthesia's low-lying fruit. Anesthesiology. 2009;111:697–698
  16. Porter ME. A strategy for health care reform—toward a value-based system. N Engl J Med. 2009;361:109–112
  17. Brody H. Medicine's ethical responsibility for health care reform—the top five list. N Engl J Med;362:283–285.
  18. CMS Pub. 100-07 Clarifications of the Interpretive Guidelines for the Anesthesia Services Condition of Participation, and Revised Hospital Anesthesia Services Interpretive Guidelines – State Operations Manual (SOM) Appendix A, S&C-10-09-Hospital. Centers for Medicare & Medicaid Services December 11, 2009.

 Conflicts of interest The authors disclose the following: J.A. Walker is CEO of Dr. NAPS, LLC; T. Wehrmann received speaker's fees and research support from Fresenius-Kabi, Germany; A. Riphaus received speaker's fees from Fresenius-Kabi, Falk Pharma and Nycomed, Germany, and research support from Fresenius-Kabi, Germany. The remaining authors disclose no conflicts.

PII: S0016-5085(10)00397-5

doi:10.1053/j.gastro.2010.03.042

Refers to article:

  • Non-Anesthesiologist Administered Propofol: Lessons Learned From Florida , 22 March 2010

    Jeffrey Jacobs, Hector Vila
    Gastroenterology May 2010 (Vol. 138, Issue 5, Page 2022)

Gastroenterology
Volume 138, Issue 5 , Pages 2022-2024, May 2010

Article Tools