Keith S Gersin

Carolinas HealthCare System, Charlotte, North Carolina, United States

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Publications (48)146.8 Total impact

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    ABSTRACT: Revisional bariatric procedures are on the rise. The higher complexity of these procedures has been reported to lead to increased risk of complications. The objective of our study was to compare the perioperative risk profile of revisional bariatric surgery with primary bariatric surgery in our experience. A prospectively maintained database of all patients undergoing bariatric surgery by three fellowship-trained bariatric surgeons from June 2005 to January 2013 at a center of excellence was reviewed. Patient demographics, type of initial and revisional operation, number of prior gastric surgeries, indications for revision, postoperative morbidity and mortality, length of stay, 30-day readmissions, and reoperations were recorded. These outcomes were compared between revisional and primary procedures by the Mann-Whitney or Chi square tests. Of 1,556 patients undergoing bariatric surgery, 102 patients (6.5 %) underwent revisional procedures during the study period. Indications for revisions included inadequate weight loss in 67, failed fundoplications with recurrent gastroesophageal reflux disease in 29, and other in 6 cases. Revisional bariatric procedures belonged into four categories: band to sleeve gastrectomy (n = 23), band to Roux-en-Y gastric bypass (n = 25), fundoplication to bypass (n = 29), and other (n = 25). Revisional procedures were associated with higher rates of readmissions and overall morbidity but no differences in leak rates and mortality compared with primary procedures. Band revisions had similar length of stay with primary procedures and had fewer complications compared with other revisions. Patients undergoing fundoplication to bypass revisions were older, had a higher number of prior gastric procedures, and the highest morbidity (40 %) and reoperation (20 %) rates. In experienced hands, many revisional bariatric procedures can be accomplished safely, with excellent perioperative outcomes that are similar to primary procedures. As the complexity of the revisional procedure and number of prior surgeries increases, however, so does the perioperative morbidity, with fundoplication revisions to gastric bypass representing the highest risk group.
    Surgical Endoscopy 08/2013; · 3.43 Impact Factor
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    ABSTRACT: Nonalcoholic fatty liver disease (NAFLD) represents the most common cause of chronic liver disease in the USA. Biopsy has been the standard for determining fibrosis but is invasive, costly, and associated with risk. Previous studies report a calculated "NAFLD fibrosis scores" (cNFS) as a means to overcome the need for biopsy. We compared cNFS versus biopsy-pathological scoring for patients undergoing bariatric surgery. We retrospectively reviewed patients with available preoperative labs and patient information undergoing Roux-en-Y gastric bypass (RYGBP) surgery at a single institution over a 5.5-year period. Biopsy samples were blind scored by a single hepatopathologist and compared with scores calculated using a previously reported cNFS. Of the 225 patients that met the inclusion criteria, the mean body mass index was 44.6 ± 5.4 kg/m(2) and 85 % were female. Using the cNFS, 39.6 % of patients were categorized into low fibrosis, 52 % indeterminate, and 8.4 % high fibrosis groups. Analysis of fibrosis by pathology scoring demonstrated 2 of 89 (2.2 %) and 7 of 110 (3.4 %) had significant fibrosis in the low and intermediate groups, respectively. Conversely, in the high fibrosis group calculated by cNFS, only 6 of 19 (31.6 %) exhibited significant fibrosis by pathology scoring. No definitive model for accurately predicting presence of NAFLD and fibrosis currently exits. Furthermore, under no circumstances should a clinical "NAFLD fibrosis score" replace liver biopsy at this time for RYGBP patients.
    Obesity Surgery 08/2013; · 3.10 Impact Factor
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    ABSTRACT: BACKGROUND: In 2008, the Realize Band (RB) adopted a precurved design (RB-C). We present 2-year outcomes data from the first multiinstitutional study of RB-C. The objective of this study was to analyze weight loss and safety data from bariatric practices in the United States, including academic, nonacademic, public, and private. METHODS: The study included adult RB-C patients with a preoperative body mass index (BMI)≥40 kg/m(2) or>35 kg/m(2) with co-morbidity. Exclusions included RB-C's label contraindications for use. Outcomes parameters were percent excess weight loss (%EWL), BMI change, number and volume of band adjustments, and adverse events. RESULTS: A total of 231 patients met inclusion/exclusion criteria. Of these, 161 had 24-month data available. Mean %EWL was 44.4%±26.9% (P<.0001). BMI decreased from 44.1±5.7 kg/m(2) to 35.3±6.9 kg/m(2) (P<.0001). Percent EWL varied by preoperative BMI (P = .0002), bariatric practice (P<.0001), aftercare frequency (P = .0004), and band fill frequency (P = .0271), but %EWL was not influenced by gender, race, or age (P>.20 each). Adverse events were dysphagia (21.2%), gastroesophageal reflux (21.6%), and vomiting (30.7%). Incidence of pouch dilation, esophageal dilation, and slippage was≤1%. Revisions (2.2%) were for unbuckled band, tube kinking, slippage, and suspected band leak (1 each). No erosions, explants, or mortality were reported. CONCLUSION: RB-C appears to be as well tolerated and effective as the first generation RB for weight loss. The near 45% EWL at 2 years is consistent with other high-quality publications on the RB. Preoperative BMI and frequency of postoperative care, including frequency of band fills, influence %EWL. Significant weight loss is achievable with RB-C despite variable postoperative management practices. The low morbidity and the absence of mortality at 24 months reflect positively on the RB-C characteristics.
    Surgery for Obesity and Related Diseases 03/2013; · 4.12 Impact Factor
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    ABSTRACT: Background Rapid weight loss after bariatric surgery is associated with gallstone formation, and cholecystectomy is required in up to 15% of patients. Prophylactic cholecystectomy or prophylactic ursodiol administration in the postoperative period have been suggested to address this problem. The objectives of this study were to investigate the frequency and timing of cholecystectomies after bariatric surgery and to determine the associated risk factors in patients who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), laparoscopic adjustable gastric band (LAGB), or laparoscopic sleeve gastrectomy (LSG). Methods Data prospectively collected in an institutional database were analyzed. Differences among the 3 procedures and the effects of ursodiol administration, patient demographic characteristics, postoperative weight loss, and individual surgeon practices on cholecystectomy rates were examined. Survival analysis and proportional hazard models were used. Results Of 1398 patients, 109 (7.8%) underwent cholecystectomy with a median follow-up of 49 (range 12–103) months. Cholecystectomy frequency was 10.6% after LRYGB, significantly higher than 2.9% after LAGB (P<.001), and 3.5% after LSG (P = .004). The frequency was highest within the first 6 months (3.7%), but declined over time to<1% per year after 3 years. Ursodiol administration did not affect cholecystectomy rates (P = .97), and significant intersurgeon variability was noted. Excess weight loss (EWL)>25% within the first 3 months was the strongest predictor of postoperative cholecystectomy (P<.001). Cox hazards model revealed 1.25 odds ratio per 10% EWL within 3 months, and odds ratio .77 per decade of life. In addition, white patients had 1.45 times higher cholecystectomy rates than did black patients. Preoperative body mass index, gender, and surgeon did not affect cholecystectomy rates. Conclusion Bariatric surgery is associated with a low frequency of postoperative cholecystectomy, which is highest early after surgery and mainly determined by the amount of EWL within the first 3 months. The results of the present study do not support routine prophylactic cholecystectomy at the time of bariatric surgery in asymptomatic patients.
    Surgery for Obesity and Related Diseases 01/2013; · 4.12 Impact Factor
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    ABSTRACT: BACKGROUND: Recent data suggest that reoperative fundoplication is associated with poor long-term control of reflux. For long-term reflux control, laparoscopic Roux-en-Y gastric bypass (LRYGB) may be a better option. This study assessed outcomes and quality-of-life data after fundoplication takedown and conversion to LRYGB for patients with failed fundoplications. METHODS: After institutional review board approval, the medical records of 25 patients who underwent fundoplication takedown and LRYGB conversion between March 2007 and July 2011 were reviewed. The data recorded included patient demographics, body mass index (BMI), preoperative symptoms, operative duration and findings, hospital length of stay (LOS), estimated blood loss (EBL), length of the follow-up period, and postoperative outcomes. The gastrointestinal quality of life index (GIQLI) and the gastrointestinal symptoms rating scale (GSRS) were used at the most recent follow-up visit to assess symptom severity and quality of life. RESULTS: The patients in this study had undergone 40 total prior antireflux surgeries. They had a median age of 55 years (range 36-72 years), a BMI of 34.4 kg/m(2) (range 22-50 kg/m(2)), an operative duration of 345 min (range 180-600 min), an EBL of 181 ml (range 50-500 ml), and an LOS of 7 days (range 2-30 days). Five patients had concomitant incisional hernia repair. There was no mortality. Of the 10 patients (40 %) who had had complications, 5 required reoperation. During a 14-month follow-up period (range 1-48 months), 96 % of the patients were reflux-free with a GIQLI score of 114 (range 80-135) and a GSRS score of 25 (range 17-45). Excess weight loss was 60 %, and comorbidity resolution was 70 %. Most of the patients (96 %) were satisfied with their outcome and would undergo the surgery again, and 62 % reported that their personal relationships and sexual life had improved. CONCLUSIONS: Patients who undergo LRYGB after failed fundoplications have excellent symptomatic control of reflux, excellent quality of life, and high rates of satisfaction with their outcome. Nevertheless, because the procedure is challenging and associated with considerable morbidity, it should be performed by surgeons experienced in antireflux and bariatric surgery.
    Surgical Endoscopy 06/2012; · 3.43 Impact Factor
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    ABSTRACT: To evaluate safety, weight loss, and cardiometabolic changes in obese subjects implanted with the duodenal-jejunal bypass liner (DJBL) for 1 year. The DJBL is an endoscopic implant that mimics the duodenal-jejunal bypass component of the Roux-en-Y gastric bypass. Previous reports have shown significant weight loss and improvement in type 2 diabetes for up to 6 months. Morbidly obese subjects were enrolled in a single arm, open label, prospective trial and implanted with the DJBL. Primary endpoints included safety and weight change from baseline to week 52. Secondary endpoints included changes in waist circumference, blood pressure, lipids, glycemic control, and metabolic syndrome. The DJBL was implanted endoscopically in 39 of 42 subjects (age: 36 ± 10 years; 80% female; weight: 109 ± 18 kg; BMI: 43.7 ± 5.9 kg/m); 24 completed 52 weeks of follow-up. Three subjects could not be implanted due to short duodenal bulb. Implantation time was 24 ± 2 minutes. There were no procedure-related complications and there were 15 early endoscopic removals. In the 52-week completer population, total body weight change from baseline was -22.1 ± 2.1 kg (P < 0.0001) corresponding to 19.9 ± 1.8% of total body weight and 47.0 ± 4.4% excess of weight loss. There were also significant improvements in waist circumference, blood pressure, total and low-density lipoprotein cholesterol, triglycerides, and fasting glucose. The DJBL is safe when implanted for 1 year, and results in significant weight loss and improvements in cardiometabolic risk factors. These results suggest that this device may be suitable for the treatment of morbid obesity and its related comorbidities. This study was registered at www.clinicaltrials.gov (NCT00985491).
    Annals of surgery 04/2012; 255(6):1080-5. · 7.90 Impact Factor
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    ABSTRACT: In 2008, the REALIZE Band (RB) adopted a precurved design (RB-C). The present study is the first multi-institutional report of RB-C outcomes. Our objective was to analyze the 1-year weight loss and safety data from adult RB-C patients treated at multiple U.S. centers (7 typical U.S. bariatric practices, including academic, nonacademic, public, and private practice). Patients implanted with the RB-C (preoperative body mass index ≥ 40 kg/m(2) or >35 kg/m(2) with co-morbidity) were recruited. The exclusion criteria included the RB-C label contraindications for use. The outcomes parameters were the percentage of excess weight loss (%EWL), change in body mass index, number and volume of band adjustments, and incidence of complications. Of the 239 patients enrolled in the 2-year study, 158 had 1-year data available for analysis in November 2010. The mean %EWL was 39.2% ± 20.5% (range -7.7 to -116.8, P < .0001). The body mass index decreased from 44.4 ± 5.5 kg/m(2) to 36.4 ± 5.8 kg/m(2) (P < .0001). The variability in the %EWL was significant among the study centers (P < .0001). The average band fill volume at 1 year was 8.0 ± 2.0 mL (range .0-11.1). The total fill volume was >11 mL in 1 patient. No band erosions/migrations, explants, or deaths occurred. RB-C appears to be as safe and effective as the first-generation RB. The near 40% EWL at 1 year was consistent with other high-quality publications of the RB. Good weight loss results are achievable, despite the varying postoperative management practices. The low morbidity and the absence of mortality at 12 months reflect positively on the RB-C characteristics. Our findings suggest that the learning curve, related to the postoperative management of the RB-C, might vary by practice and that a greater frequency and smaller band fills might result in better weight loss at 12 months.
    Surgery for Obesity and Related Diseases 05/2011; 8(3):288-95. · 4.12 Impact Factor
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    ABSTRACT: Student observation of surgical procedures is standard practice performed at the discretion of the attending surgeon and the participating medical facility. The goal of our study was to evaluate patient, physician, and operating room (OR) staff opinions concerning student observation of surgical procedures at different levels of academic training. Following Institutional Review Board approval, patients undergoing elective surgery were consented to participate in the survey. An anonymous online survey was sent to attending surgeons and OR staff. The majority of patients (97), physicians (91), and OR staff (71) believe that OR observational experience is important to medical student training. Patients (92%) and OR staff (97%) more so than physicians (72%) rated OR observational experience as important for nursing student education (P < 0.001). Comparatively, all groups believe this experience is less important for college and high school students (P < 0.01). When asked if patients should be informed preoperatively of student-observer presence during procedures, more patients and OR staff replied affirmatively compared with physicians (P < 0.001). Similarly, patients and OR staff more frequently believed that informed consent for OR student-observers was necessary (P < 0.0001). All groups acknowledged the educational value of student observational experience, although significant disparity was noted relative to academic level and the group responding. Additionally, opinions of the OR staff were more closely aligned with those of patients. Further assessment of the role of informed consent for student-observer OR presence and potential implications is needed.
    Journal of Surgical Research 04/2011; 170(2):195-201. · 2.02 Impact Factor
  • Article: Response.
    Gastrointestinal endoscopy 04/2011; 73(4):851-2. · 6.71 Impact Factor
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    ABSTRACT: The ideal length of the gastric bypass limbs is debated. Recent evidence suggests that standard limb lengths used today have a limited impact on patient weight loss. Our objective was to appraise critically the available evidence on the influence of the length of gastric bypass limbs on weight loss outcomes. We systematically reviewed MEDLINE, the Cochrane database of evidence-based reviews, and the Database of Abstracts of Reviews of Effects for articles reporting the effect of gastric bypass length on outcomes published between 1987 and 2009. Four randomized controlled trials and several retrospective studies were identified and reviewed. Longer Roux limb lengths (at least 150 cm) were associated with a very modest weight loss advantage in the short term in superobese patients. No significant impact of alimentary limb length on weight loss for patients with body mass index (BMI) <50 was seen. When the length of the common channel approaches 100 cm, a significant impact on weight loss is observed. The currently available literature supports the notion that a longer Roux limb (at least 150 cm) may be associated with a very modest weight loss advantage in the short term in superobese patients but has no significant impact on patients with BMI ≤50. To achieve weight loss benefit due to malabsorption, bariatric surgeons should focus on the length of the common channel rather than the alimentary or biliopancreatic limbs when constructing a gastric bypass especially in the superobese population where failure rates after conventional gastric bypass are higher.
    Obesity Surgery 01/2011; 21(1):119-24. · 3.10 Impact Factor
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    ABSTRACT: The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight. The present study examined the effect of variations in IBW and the preoperative weight on the %EWL at a tertiary care teaching hospital. After institutional review board approval, we reviewed the prospectively collected data from consecutive patients who had undergone laparoscopic adjustable gastric banding or laparoscopic Roux-en-Y gastric bypass (RYGB) at our center from 2005 to 2008 with a single surgeon (T.K.). All patients with ≥12 months of follow-up were included. The IBW was calculated using the mean weight of the "medium frame" and the maximum weight of the "large frame" for the corresponding height from the Metropolitan Life Insurance tables. The preoperative weight was defined as the weight on the day of surgery or the greatest recorded preoperative weight between the initial consult and the day of surgery. The postoperative weight was defined as the 12-month follow-up weight. Four methods were used to calculate the %EWL. Repeated measures analysis of variance was used to analyze the methods. A total of 173 patients met inclusion criteria. Of these 173 patients, 126 underwent RYGB and 47 underwent laparoscopic adjustable gastric banding. The calculated 12-month %EWL for these was 65-82% for RYGB and 31-46% for laparoscopic adjustable gastric banding using the calculation method. For a given postoperative weight loss, significant variance will be found in the %EWL (≤17%), depending on the definition of IBW used and the preoperative weight value used. This highlights the need for a standardized approach for reporting weight loss in bariatric studies. Investigators should define their methods clearly, and readers should keep this variability in mind when interpreting the %EWL.
    Surgery for Obesity and Related Diseases 01/2011; 7(4):531-4. · 4.12 Impact Factor
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    ABSTRACT: The amount of excess weight loss (EWL) achieved after bariatric surgery has varied considerably. Reliable preoperative predictors of the postoperative %EWL do not exist. Patient compliance with the physician recommendations has generally been believed to be important for long-term success after bariatric surgery, especially after gastric banding. We hypothesized that poor preoperative patient compliance with office visits, a likely indicator of overall compliance, would be associated with lower %EWL after bariatric surgery at a teaching hospital in the United States. We performed an institutional review board-approved review of prospectively collected data from all patients undergoing bariatric surgery from 2007 to 2009. The patients were categorized into 2 groups: those who had missed <25% of all preoperative appointments at our bariatric center and those who had missed >25%. The average %EWL at 12 months between the 2 groups was compared using the unpaired t test separately for the gastric bypass and gastric banding patients. The gastric band patients with >25% missed appointments had lost 23% EWL at 12 months compared with 32% EWL for the gastric band patients who had missed <25% of their appointments (P = .01). No difference was found in the %EWL for the gastric bypass patients according to the missed preoperative appointments. The postoperative compliance was significantly poorer than preoperatively. The patients with a greater percentage of missed preoperative appointments had a lower postoperative %EWL at 1 year after gastric banding but not after gastric bypass. This information could prove useful during patient selection or when counseling patients about the type of bariatric surgery to pursue.
    Surgery for Obesity and Related Diseases 12/2010; 7(6):743-8. · 4.12 Impact Factor
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    Revista Chilena de Cirugia 06/2010; 62:234-239. · 0.18 Impact Factor
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    ABSTRACT: The duodenal-jejunal bypass liner is an endoscopically placed and removable intestinal liner that creates a duodenal-jejunal bypass, leading to diabetes improvement and weight loss. The aim of the present study was to evaluate the clinical effects and safety of the duodenal-jejunal bypass liner combined with a restrictor orifice (flow restrictor). The device was endoscopically implanted in 10 patients (body mass index 40.8 +/- 4.0 kg/m(2)) and removed after 12 weeks. Dilation of the restrictor orifice was performed as clinically indicated with a 6-, 8-, or 10-mm diameter through-the-scope balloon. The measured outcomes included the percentage of excess weight loss, total weight loss, adverse events, and gastric emptying (GE) at baseline, weeks 4 and 12 of implantation, and 3-5 months after device removal. GE was measured by scintigraphy at 1, 2, and 4 hours after implantation. The percentage of excess weight loss and total weight loss at explantation was 40% +/- 3% (range 21-64%) and 16.7 +/- 1.4 kg (range 12.0-26.0), respectively. The 4-hour GE was 98% +/- 1% at baseline, 72% +/- 6% at 4 weeks (P = 0.001 versus baseline), and 84% +/- 5% at 12 weeks (P <.05 versus baseline). After explantation, the rate of GE returned to normal in 7 of 8 subjects, but remained slightly delayed in 1 subject (84% at 4 hours). Episodes of nausea, vomiting, and abdominal pain required endoscopic dilation of the restrictor orifice with a 6-mm through-the-scope balloon in 7 patients and a 10-mm balloon in 1, with no clinically significant adverse events. Endoscopic implantation of a combination flow restrictor and duodenal-jejunal bypass liner induced substantial weight loss. The implanted patients exhibited delayed GE that was reversed after device removal.
    Surgery for Obesity and Related Diseases 03/2010; 6(2):126-31. · 4.12 Impact Factor
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    ABSTRACT: The duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in weight loss and improvement in type 2 diabetes mellitus. Weight loss before bariatric surgery to decrease perioperative complications. Prospective, randomized, sham-controlled trial. Multicenter, tertiary care, teaching hospitals. Twenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population. The subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling. The primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety. Thirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% +/- 1.4% and 2.7% +/- 2.0% for the DJBL and sham arms, respectively (P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm (P < .05). Total weight change in the DJBL arm was -8.2 +/- 1.3 kg compared with -2.1 +/- 1.1 kg in the sham arm (P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation. Study personnel were not blinded. There was a lack of data on caloric intake. The DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. (Clinical trial registration number: NPT00469391.).
    Gastrointestinal endoscopy 03/2010; 71(6):976-82. · 6.71 Impact Factor
  • Gastroenterology 01/2010; 138(5). · 12.82 Impact Factor
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    ABSTRACT: Bowel obstructions following Roux-en-Y gastric bypass (RYGB) are a significant issue often caused by internal herniation. Controversy continues as to whether mesenteric defect closure is necessary to decrease the incidence of internal hernias after RYGB. Our purpose was to evaluate the effectiveness of closing the mesenteric defect at the jejunojejunostomy in patients who underwent RYGB by examining this potential space at reoperation for any reason. We retrospectively reviewed medical records of patients undergoing surgery after RYGB from August 1999 to October 2008 to determine the status of the mesentery at the jejunojejunostomy. Eighteen patients underwent surgery 2 to 19 months after open (n=8) or laparoscopic (n=10) RYGB. All patients had documented suture closure of their jejunojejunostomy at the time of RYGB. Permanent (n=12) or absorbable (n=6) sutures were used for closures. Patients lost 23.6 kg to 62.1 kg before a reoperation was required for a ventral hernia (n=8), cholecystectomy (n=4), abdominal pain (n=4), or small bowel obstruction (n=2). Fifteen of the 18 patients had open mesenteric defects at the jejunojejunostomy despite previous closure; none were the cause for reoperation. Routine suture closure of mesenteric defects after RYGB may not be an effective permanent closure likely due to the extensive fat loss and weight loss within the mesentery.
    JSLS: Journal of the Society of Laparoendoscopic Surgeons / Society of Laparoendoscopic Surgeons 01/2010; 14(2):213-6. · 0.81 Impact Factor
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    ABSTRACT: Methods: A modified DJBL was implanted in 61 subjects in two prospective, single arm studies at two institutions in Brazil and Chile. One study enrolled 39 subjects who were obese with a mean BMI of 43.8 + 0.9 kg/m 2 (range: 35.4-58.2 kg/m 2 ) while a second study enrolled 22 subjects who were obese with a mean BMI of 44.9 + 1.6 kg/m 2 (range: 35.6-59.6 kg/m 2 ) and with type 2 diabetes. These subjects had a mean baseline HbA1c of 8.9 + 0.4% (range: 6.7-11.6%). Assessments in both trials were similar and included monthly weights and safety evalua- tions. The diabetes trial also assessed HbA1c at all post-implant follow-up visits. All subjects were placed on a liquid diet for the first week post-implant, followed by a low-calorie diet for the remainder of the 24 weeks. Results: The change in subject weights at 24 weeks (n=48) were -15.0+1.1Kg (-27.0+1.7%EW, -13.1.0+0.9%TBW, see Figure 3). In the diabetes study at week 24 (n=16), the change in HbA1c was -1.5±0.4% while 58% of the subjects (7/12 with data) achieved HbA1c of 7% or less (see Figure 4). Implant delivery times were 26.0+ 1.6 minutes and used 8.0+0.5 minutes of fluoroscopy. Removal procedures took 11.0+3.0 minutes and used 1.9+1.0 minutes of fluoroscopy. There was one mi- gration of the DJBL prior to 24 weeks (1.6%), a significant improvement (p< 0.05) over the first generation design (31%). There were an additional 8 early removals due to device-related adverse events including GI bleeding (1) and GI pain or dis- comfort (7). All implants were removed endoscopically. Conclusions: The improvement in glycemic control and weight loss seen with the DJBL at 3 months continues during 6 months of implantation. The stability of the DJBL was enhanced with minor anchor modifications as evidenced by fewer migrations. The DJBL is a promising development in the search for less invasive therapies for the treatment of type 2 diabetes and morbid obesity.
    Gastrointestinal Endoscopy - GASTROINTEST ENDOSCOP. 01/2010; 71(5).
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    ABSTRACT: Bariatric surgery is associated with the rapid improvement of type 2 diabetes (T2DM). Here we report an exploratory trial of a completely endoscopic, removable, duodenal-jejunal bypass liner (DJBL) intended to treat T2DM. Obese T2DM subjects were randomized to receive a DJBL (n = 12) or sham endoscopy (n = 6) in a 24-week study, extended up to 52 weeks. Measurements included weights, hemoglobin A1c (HbA(1c)), meal tolerance testing, fasting glucose, and seven-point glucose profiles. Subjects' diets were adjusted in the first 2 weeks to obtain similar weight loss during this period. Subjects had baseline HbA(1c) of 9.1 +/- 1.7% and body mass index of 38.9 +/- 6.1 kg/m(2) (+/- SD). In the completer population by week 1, change in fasting glucose in the DJBL arm was -55 +/- 21 mg/dL versus +42 +/- 30 mg/dL in the sham arm (P < or = 0.05; +/- SE); the seven-point glucose profiles were reduced in the DJBL arm but not in the sham arm. Mean postprandial glucose area under the curve was reduced in the DJBL arm by 20% and increased 17% in the sham arm (P = 0.016). At week 12, HbA(1c) change was -1.3 +/- 0.9% in the DJBL arm and -0.7 +/- 0.4% in the sham arm (P > 0.05), and at 24 weeks, values were -2.4 +/- 0.7% in the DJBL arm and -0.8 +/- 0.4% in the sham arm (P > 0.05). Device migrations required endoscopic removal prior to reaching 52 weeks. The DJBL rapidly normalized glycemic control in obese T2DM subjects, a promising development in the search for novel therapies less invasive than bariatric surgery.
    Diabetes Technology &amp Therapeutics 11/2009; 11(11):725-32. · 2.21 Impact Factor
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    ABSTRACT: IntroductionThe addition of staple-line reinforcements on circular anastomoses has not been well studied. We histologically and mechanically analyzed circular- stapled anastomoses with and without bioabsorbable staple-line reinforcement (SeamGuard®, W. L. Gore & Associates, Flagstaff, AZ) in a porcine model. MethodsGastrojejunal anastomoses were constructed using a #25 EEA Proximate ILS® (Ethicon Endo-Surgery, Cincinnati, OH) mechanical stapling device with and without Bioabsorbable SeamGuard® (BSG). Gastrojejunal anastomoses were resected acutely and at 1week, and burst-pressure testing and histological analysis were performed. Standardized grading systems for inflammation, collagen deposition, vascularity, and serosal inflammation were used to compare the two anastomosis types. ResultsAcute burst pressures were significantly higher with BSG than with staples alone (1.37 versus 0.39 psi, p=0.0075). Burst pressures at 1week were significantly lower with BSG than with staples alone (2.24 versus 3.86 psi, p=0.0353); however, both readings were above normal physiologic intestinal pressures. There was no statistical difference in inflammation (13.4 versus 15.6, p=0.073), width of mucosa (3.2mm versus 3.2mm, p=0.974), adhesion formation (0 versus 0.5, p=0.575), number of blood vessels (0.5 versus 1.0, p=0.056), or serosal inflammation (2.0 versus 1.0, p=0.27) between the stapled anastomoses and those buttressed with BSG. Stapled-only anastomoses had statistically more collagen (2.0 versus 1.0, p=0.005) than the anastomoses supported with BSG. ConclusionsThe addition of BSG as a staple-line reinforcement acutely improves the burst strength of a circular anastomosis but not at 1week. At 1week, a decrease in collagen content with the BSG-buttressed stapled anastomosis was the only difference in the histologic parameters studied with no difference in vascularity, adhesions, or inflammation. The long-term effect of BSG on anastomotic strength or scarring is yet to be determined. The clinical implications may include decreased stricture formation and also decreased strength at anastomoses.
    Surgical Endoscopy 04/2009; 23(4):800-807. · 3.43 Impact Factor

Publication Stats

463 Citations
146.80 Total Impact Points

Institutions

  • 2013
    • Carolinas HealthCare System
      Charlotte, North Carolina, United States
  • 2012
    • Pontifical Catholic University of Chile
      • Departamento de Cirugía Digestiva
      CiudadSantiago, Santiago, Chile
  • 2007–2012
    • Carolinas Medical Center University
      Charlotte, North Carolina, United States
  • 2009–2010
    • University of North Carolina at Charlotte
      Charlotte, North Carolina, United States
  • 2002–2003
    • University of Cincinnati
      • Department of Surgery
      Cincinnati, OH, United States
  • 2001–2003
    • Massachusetts Medical Society
      United States
  • 2000
    • University of Massachusetts Medical School
      • Department of Surgery
      Worcester, MA, United States