ASBS - Comment on Recent JAMA Articles

The recent articles in JAMA ^1-3, have raised several concerns regarding the safety of bariatric surgery, some of which may not be justified.

With regards to the mortality risk, the report by Santry et al ² from the National Inpatient Sample (NIS) noted an 0.1 to 0.2% inpatient mortality nationwide and the Zigmund et al study ³ noted an 0.18% inpatient mortality and an 0.33% 30-day mortality in the State of California using the State’s Patient Discharge Database for gastric bypass. These are much lower than a previous report by Flum and Dellinger from the Washington State ⁴ which noted a 1.9% 30-day mortality following bariatric surgery. Like these reports from JAMA, the earlier Flum and Dellinger study received an enormous amount of negative press coverage stating that the mortality of bariatric surgery was much greater than single series studies suggested ⁵. Yet the mortality in California is actually lower than many of these case series reports. Why the discrepancy between the mortality in these two states? Could the better results be due to centers which perform greater numbers of bariatric surgical procedures and are therefore more proficient in their surgical technique and patient care or are there more Medicare and Medicaid patients in the Washington State data-base? Are the California surgeons operating on lower risk patients? We clearly need a prospective data-base with risk adjustment to get a true idea of the risks of bariatric surgery. This is emphasized in the studies where the Charlson Index, as coded in the discharge data-base, was used to estimate co-morbidities. This measurement suggested that 50-60% of these morbidly obese patients had no co-morbidities; whereas, it is clear that almost 100% of severely obese patients have one or more co-morbidities. A prospective data-base is a major component of the Bariatric Centers of Excellence program being developed by the American Society for Bariatric Surgery (ASBS) under contract with the Surgical Review Corporation (www.surgicalreview.org).

The study by Flum et al ¹ found a much higher mortality amongst Medicare patients than had previously been reported for bariatric surgical procedures ⁵. This is no surprise, since 90% of patients who undergo bariatric surgery with Medicare coverage are social security disabled and < 65. These are the sickest patients, almost certainly a consequence of their obesity and, therefore, have the greatest risk of surgery. They may cost more to undergo the surgery than the surgeon or the hospital are reimbursed which may be one of the reasons that they are under-represented in the frequency of procedures noted in the Santry et al study ². Of greater concern is the increased mortality noted by Flum et al in those ≥ 65. Several studies have noticed an increased mortality associated with age ^6-8. However, the data may not be as grim as the press has reported. The Flum et al study noted that those centers who have the highest number of Medicare cases (and it may be presumed the greatest number of bariatric procedures regardless of status) had a 30-day mortality rate in those ≥ 65 of 1.1%, a very reasonable number in this age group. In our single series study of 80 patients ≥ 60, of whom 21 were ≥ 65, we had no deaths at one year ³, as also reported in another series of 27 patients, of whom 13 had a laparoscopic gastric bypass ≥ 65 ¹⁰. It would be nice to have a randomized, prospective or cohort trial in this group of patients, but as only about 200 patients ≥ 65 undergo bariatric surgery annually in the United States, limiting each center to one to three cases/year, it will be extremely difficult to perform such a study. A more reasonable approach would be to limit access to this surgery to ASBS Centers of Excellence which mandates these centers to perform ≥ 125 cases/year with surgeons who perform ≥ 50 cases/year and have processes and facilities designed to optimize the care of the bariatric patient and then collect and analyze the outcomes of these Centers on an annual basis.

Lastly, there are serious concerns regarding the study by Zigmund et al which noted the marked increase in readmissions in the three years after bariatric surgery as compared to the three years preceding bariatric surgery ³. There are three groups in this study which warrant further comment. Early readmissions for endoscopy (16%), hypovolemia (6%), nausea and vomiting (4%) are probably interrelated and may be associated with pressures for early hospital discharge, are likely of short duration and low cost and could probably be avoided in many patients with outpatient management. The second group are readmissions for hernia without [6 (early)-13% (late)] and with complication (3-4%), wound complication (6-4%), ventral hernia repair (8-15%), lysis of adhesions (5-4%), wound incision & drainage (5-5%) and are almost certainly related to the high frequency of open bariatric surgery during the time period of this study, a group of complications virtually eliminated with the laparoscopic approach which is currently much more prevalent. The third is one for which patients have undergone plastic surgical procedures following their surgically induced weight loss (2-11%), a benefit of the surgery and rarely covered by health insurance. Furthermore, the orthopedic procedures (hip and knee replacement) are much more likely to be successful following surgically induced weight loss. Lastly, the costly and life-threatening readmissions for serious medical conditions such as chest pain, coronary artery disease, congestive heart failure, obstructive lung disease, and cellulitis were all decreased following bariatric surgery. Readmissions for life-threatening complications of the surgery (leak, internal hernia) are of concern but represent a minority of the cases. Again this study noted that surgery performed at a low volume medical center was more likely to result in hospital readmissions.

There is no other effective treatment for these severely obese patients. Their co-morbidities extend from the head to the toe and affect every organ in-between. An alternative conclusion that can be reached regarding each of these reports is that bariatric surgery performed in an approved high volume Center of Excellence can provide profound improvements in obesity co-morbidities and quality of life, at a reasonable cost and with low rates of mortality and morbidity.

Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005;294:1903-1908.
Santry HP, Gillen DI, Lauderdale DS. Trends in bariatric surgical procedures. JAMA 2005;294:1909-1917.
Zingmund DS, McGory ML, Ko CY. Hospitalization before and after gastric bypass surgery. JAMA 2005;294:1918-1924.
Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based survey. J Am Coll Surg 2004;199:543-551.
Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292:1724-1737.
Gonzalez R, Lin E, Mattar SG, Venkatesh KR, Smith CD. Gastric bypass in morbidly obese patients 50 years or older. Am Surg 2003:69:547-553.
Livingston EH, Huerta S, Arthur D, Lee S, DeShields S, Heber D. Male gender is a predictor of morbidity and age a predictor of mortality for patients undergoing gastric bypass surgery. Ann Surg 2002;236:576-582.
Soso JL, Pombo H, Pallavicini H, Ruiz-Rodriguez M. Laparoscopic gastric bypass beyond age 60. Obes Surg 2004;14:1398-1401.
Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004;240:243-247.
Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R.
Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005;1: 389-392.

Harvey J. Sugerman, MD
Immediate Past President
American Society for Bariatric Surgery