Letters 5. O’Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term Corresponding Author: Paul O’Brien, MD, FRACS, Centre for Obesity Research outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric and Education, Monash University, 40 Murphy St, South Yarra, VIC 3141, banding and a systematic review of the bariatric surgical literature. Ann Surg. Australia (email@example.com). 2013;257(1):87-94. Published Online: December 27, 2017. doi:10.1001/jamasurg.2017.4513 Conflict of Interest Disclosures: Dr Brown reports that her research group (Centre for Obesity Research and Education of Monash University) receives To the Editor Ibrahim et al report that for Medicare beneficia- funding from the manufacturer of the LapBand (Allergan and Apollo Endosurgical) as well as from Applied Medical. She has received honorarium ries, reoperation after laparoscopic adjustable gastric band- from Merck Sharp and Dohme for lectures and from Novo Nordisc for ing (LAGB) is common and costly. They suggest payers should participation on a Scientific Advisory Panel. She has also received funding for a reconsider coverage for the procedure. They do not reference bariatric surgery registry from the Commonwealth of Australia, Johnson and Johnson, Covidien/Medtronic, GORE, Applied Medical, Apollo Endosurgery, and strong comparative data on the alternative procedures. Most Allergan. No other disclosures were reported. significantly, they report wide variation in outcomes. Across 1. Ibrahim AM, Thumma JR, Dimick JB. Reoperation and Medicare expenditures the 306 studied hospital referral regions, the reoperation rates after laparoscopic gastric band surgery. JAMA Surg. 2017;152(9):835-842. varied from 5% to 95% (interquartile range, 13-39). It is clearly 2. O’Brien P, McDonald L, Anderson M, Brennan L, Brown WA. Long term a mix of good and bad. We believe that analysis of this varia- outcomes after bariatric surgery: fifteen year follow up after gastric banding and tion is enlightening. a systematic review of the literature. Ann Surg. 2013;257:87-94. The LAGB procedure is unique among surgical proce- 3. Gould JC. Considering the role of the laparoscopic adjustable gastric band: dures. The placement of the device by itself does very little; it do not throw the baby out with the bathwater. JAMA Surg. 2017;152(9):842. will not achieve the outcome of substantial and durable weight loss with minimal symptoms. It simply sets the scene for the In Reply We appreciate the opportunity to reply to the thought- aftercare program, consisting of adjustment of the device to ful letters from Fielding as well as O’Brien and Brown regard- achieve satiety as well as education and support of the pa- ing our study on reoperation rates following laparoscopic tient for correct eating after LAGB placement. adjustable gastric band placement for morbid obesity. Their As with a 3-legged stool, effectiveness of LAGB requires 3 comments together raise 2 important points that apply to stable supports; each of the band, the patient, and the clini- the gastric band as well as medical devices more broadly: cian must perform optimally. The band is not subject to varia- (1) how should costs be factored into evaluating a new medi- tion, and variations in patients are unlikely to be reflected by cal device? and (2) how should we address the problem of varia- hospital referral regions. Therefore, the principal variation is tion in outcomes after a new device or procedure is widely likely to be the clinician—the surgeons, physicians, and other adopted? health care professionals involved in the procedure and the af- Our study was not designed to be a comprehensive com- tercare process. parative cost-effectiveness analysis of the gastric band to treat We know the LAGB procedure can achieve durable effec- morbid obesity. Nonetheless, it does raise concern about the tiveness. We reported on 3227 patients with up to 15 years of resource utilization of public payers (eg, Medicare) to revise follow-up, at which time they still had 47% excess weight lost. or remove the device. Our point was not to say that because For the 5 years from 2006 to 2010, we observed a 13.1% revi- reoperations are so costly, we ought to drop coverage of the sion rate and a 2.2% reversal rate compared with the 41.8% device. Instead, our study was meant to identify high reop- band reversal rate over 4.5 years seen in the report by Ibra- eration costs as a warning sign that there may be a problem with him et al. Others in the United States, Europe, and elsewhere the device or how it is being used to prompt further investi- have demonstrated equivalent satisfactory outcomes. gation. Cost utilization for reoperation is not an unprec- We support the message of Gould’s Invited Commentary, edented approach to monitor the safety and effectiveness of “Considering the Role of the Laparoscopic Adjustable Gastric medical devices. A 2017 report from the US Office of the In- Band: Do Not Throw the Baby Out With the Bathwater.” spector General summarizing an audit of Medicare claims iden- There is good to be had with LAGB if the clinician leg of the tified more than $1.5 billion in payments for removal of faulty stool is solid, which includes correct placement combined or premature medical devices, thereby identifying devices that with knowledgeable and committed aftercare. The wide need further evaluation. Because costs can be captured in ad- variation noted by Ibrahim et al suggests that some in the ministrative data in real time, it becomes a readily accessible clinician group are knowledgeable and committed and that measure to begin evaluating a device longitudinally and to others are less so. Resource allocation, particularly adequate identify early warning signs. funding of aftercare, is a key driver of commitment. The As pointed out by O’Brien and Brown, the story of the lapa- solution is not to walk away from a safe, gentle, and effective roscopic adjustable gastric band is also about widespread varia- procedure but rather to train the clinician better, encourage tion in outcomes after it was broadly adopted. We observed patients toward clinicians who are committed, and provide that hospital referral regions demonstrated reoperation rates them with adequate resources. ranging from 5% to 95%. How, then, should we address this variation? As pointed out in our Discussion section, there are Paul O’Brien, MD, FRACS several approaches: payers could restrict reimbursing the de- Wendy Brown, MBBS(hons), PhD, FRACS vice to the most experienced bariatric surgeons, regulators could require more robust training to ensure the device is being Author Affiliations: Centre for Obesity Research and Education, Monash University, South Yarra, Victoria, Australia. used appropriately, or bariatricians could revisit our indica- 190 JAMA Surgery February 2018 Volume 153, Number 2 (Reprinted) jamasurgery.com © 2017 American Medical Association. All rights reserved.
JAMA Surgery – American Medical Association
Published: Feb 27, 2018
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