In the last edition of SOARD, our clinical issues committee led by Julie Kim, MD and Ann Rogers, MD, published a statement looking at the current controversy surrounding single anastomosis duodenal switch. This new procedure, first performed in Europe, has been implemented in subjects with morbid obesity either as a primary step or as a revisional option in patients that did not respond to sleeve gastrectomy.
As it is evident from the literature analysis, the evidence of the experience with this approach is minimal. There are currently only 4 publications looking at a total number of 222 patients with follow up that varies between months to 5 years. Three of the 4 publications belong to the same group that pioneered the approach. Based on the data published so far, there insufficient evidence as to the safety, efficacy and durability of this approach.
In response to multiple queries received from patients, members, and payers, and after a lengthy discussion of the analyzed data, the Executive Council declared this procedure to be investigational and to be conducted under IRB. This recommendation is not intended to prevent or hinder innovation, but to allow innovation to be implemented into our practice while protecting our patients and members.
It is our Society’s obligation to monitor progress in the field of bariatric surgery. While the FDA oversees the implementation of new drugs and devices, there is no oversight when surgical approaches are modified or new ones are introduced.
In an effort to monitor innovation, John Morton, MD past president of ASMBS, started the “New Procedure Pathway” Committee. Every member that would like to use a new device, or a new procedure or even modify a well established one, is encouraged to fill out and send an application that will be reviewed by this special committee formed by the members of the Executive Committee, and the chairs of the quality, insurance, new technology, and clinical issues committees. The analysis of the data will be presented to the Executive Council to determine if this procedure can be conducted with or without an IRB. The single anastomosis DS is now under review for approval as a primary surgery by the New Procedure
On May 5th and 6th, I was privileged to attend the New York, Connecticut and New Jersey ASMBS State Chapter annual meeting at the New York Academy of Medicine in Manhattan, NY. The concept of gathering three neighbor state chapters for this type of meeting is an excellent one that I would like to foster across all state chapter presidents.
Turnout was great. More than 150 attended the conference, and the topics presented were extremely important. I would like to highlight Dr. Stacy Brethauer’s (ASMBS President-Elect) presentation on microbiome and its relationship to metabolic syndrome. Data published in the last five years looks at the potential role of the gut microbiome in the development of obesity and type 2 diabetes. There is evidence that obesity is associated with changes in the composition of the intestinal flora, and the obese microbiome seems to be more efficient in storing energy from the diet. Additional supporting data comes from studies showing that lean male donor fecal microbiome transplantation (FMT) in males with metabolic syndrome resulted in a significant improvement in insulin sensitivity. From the above mentioned, it seems that physical activity and changes in dietary habits might not be solely responsible for the obesity disease. (1) We look forward to further research in this area and developing new promising non surgical therapies to prevent and treat the obesity and diabetes pandemic.
I would like to conclude this message by inviting you all to join us in Las Vegas at the Aria Hotel for the annual spring event Obesity Week-End. The program looks phenomenal and the venue does not need further introduction. I also want to remind you to please cast your vote for the changes in our bylaws and to send your contribution to the PAC.
See you in Vegas!References: 1. Insights Into the Role of the Microbiome in Obesity and Type 2 Diabetes Annick V. Hartstra1, Kristien E.C. Bouter1, Fredrik Bäckhed2,3 and Max Nieuwdorp1 Diabetes Care 2015 Jan; 38(1): 159-165. http://dx.doi.org/10.2337/dc14-0769