Gastric Bypass Complications

Six additional patients have persistent severe obesity (BMI >35) at least two years post-op, but either refuse further surgery or are satisfied with the results.

Overall only four patients (11%) in our series achieved BMI <35 and/or at least 50% reduction in excess weight without complications. Two patients without complications have lost 79% and 85% of excess weight, where they remain at 113% and 117% of ideal weight, respectively. The overall need for band removal/conversion to GBP in our series will ultimately exceed 50%.

Weight loss in our series was poor. Average percent excess weight loss over three years in patients with intact bands was only 38%, despite the fact that a number of patients were deleted from the follow-up pool because of conversion to gastric bypass or band removal. There was no apparent correlation between stomal diameter and weight loss. Studies from other countries, however, report better results. For example, a study by Lise of 111 patients report a reduction in BMI from 46.4 to 33.1 kg/m2 at two years follow up.

At the FDA Advisory Panel session23 only 115 patients had been followed for three years following the procedure. Patients lost approximately one-third of excess weight and one-third of patients required either revision or removal of the device. In a series of international patients presented from Europe and Australia, surgical revision or repair of tubing or removal of the device has been necessary in 28%, the most common problem being prolapse. The mean % EWL following the procedure was 38%. In these patients, diabetes, sleep apnea, and hypertension resolved in only 22%, 40% and 55% respectively. In the Swedish Obese Subjects study,11 most patients had either vertical-banded gastroplasty or implantation of the so-called Swedish band (which differs from the current device in design, introduction method, and reported results) and had only 23% loss of body weight despite a rather low average preoperative BMI of 42 kg/m2. The authors also noted a rather disappointing 47% reduction in diabetes and 42% reduction in hypertension. Not surprisingly, their data show that the risk of retaining co-morbid conditions of dyspnea, chest pain, and physical inactivity, which persisted in 19%, 4%, and 17% of postoperative patients, respectively, decreased progressively with the degree of weight loss.

Summary

While technically relatively easy to perform this procedure, the overall weight reduction with the LASGB device is significantly less as compared to proximal gastric bypass. A procedure in which patients on average lose much less than half of their excess weight will not produce the dramatic resolution of co-morbidities seen with gastric bypass. Thus, significant co-morbidity such as diabetes and hypertension might be viewed as a relative contraindication to LASGB. An alternative viewpoint would suggest that improvement in co-morbidities in under half of patients undergoing this procedure is superior to no improvement in co-morbidities in patients who would decline superior forms of surgical intervention such as proximal gastric bypass.

Our results demonstrate that the LASGB procedure is not an efficacious procedure for treatment of morbid obesity in our population ofAmerican patients—and it is unclear why these results differ from those seen in other countries around the world. Furthermore, cultural, dietary, genetic, and metabolic factors might be implicated in the dramatic difference between weight loss in this American series as

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