Diabetes, intermittent claudication, and risk of cardiovascular events. The Framingham Study

The impact of diabetes on intermittent claudication was examined in 1813 men and 2504 women with 34-yr follow-up data in the Framingham study. For both sexes, diabetes was associated with a two- to threefold excess risk of intermittent claudication compared with its absence. A pronounced excess risk was also observed in subjects on oral hypoglycemic therapy and in women receiving insulin. Although diabetes was often associated with an atherogenic-risk profile, controlling for age and several concomitant risk factors failed to eliminate the association with intermittent claudication. Those who developed both intermittent claudication and diabetes were at an especially high risk of incident cardiovascular events. In women, the risk of coronary heart disease, stroke, and cardiac failure was increased 3-4 times when diabetes and intermittent claudication occurred together compared with when either condition existed alone. In diabetic men, the presence of intermittent claudication doubled the risk of stroke, and cardiac failure was approximately 3 times more likely in subjects with both conditions compared with either alone. We conclude that diabetes is an important risk factor for intermittent claudication, which in turn confers a serious prognosis for subsequent cardiovascular outcomes in the patient with diabetes.     

Predictors of change in cardiovascular disease risk and events following gastric bypass: a 7-year prospective multicenter study

BackgroundChange in short-term (i.e., 10-year) and lifetime risk of cardiovascular disease (CVD) following Roux-en-Y gastric bypass (RYGB) has significant heterogeneity.ObjectiveTo identify predictors of change in CVD risk and cardiovascular events following RYGB.MethodsBetween 2006–2009, 1625 adults without a history of CVD enrolled in a prospective cohort study and underwent RYGB at 1 of 10 U.S. hospitals. Participants were followed annually for a maximum of 7 years. Associations between presurgery characteristics (anthropometric, sociodemographic, physical and mental health, alcohol/drug use, eating behaviors) and 1) pre to postsurgery change in 10 year and lifetime atherosclerotic CVD (ASCVD) risk scores, respectively, and 2) having a CVD event (nonfatal myocardial infarction, stroke, ischemic heart disease, congestive heart failure, angina, percutaneous coronary intervention, coronary artery bypass grafting, or CVD-attributed death) as repeated measures (yr 1–7) were evaluated.SettingObservational cohort study at ten hospitals throughout the United States.ResultsPresurgery factors independently associated with decreases in both 10-year and lifetime risk scores 1–7 years post-RYGB were higher CVD risk score, female sex, higher household income, and normal kidney function. Additionally, Black race and having diabetes were independently associated with decreases in 10-year risk, while not having diabetes and a higher (better) composite mental health score were independently related to decreases in lifetime risk. A lower (worse) presurgery composite physical health score was associated with a higher CVD event risk (RR = 1.68, per 10 points).ConclusionThis study identified multiple presurgery factors that characterize patients who may have more cardiovascular benefit from RYGB, and patients who might require additional support to improve their cardiovascular health.     

Long-term studies of mental health after the Greenville gastric bypass operation for morbid obesity

From February 1, 1980, to May 1, 1989, 462 patients underwent the Greenville gastric bypass at the East Carolina University School of Medicine. The operation effectively maintained satisfactory weight loss after 9 years (mean weight preoperatively, 293 lbs; at 24 months, 179 lbs; at 96 months, 194 lbs). The gastric bypass favorably affected non-insulin-dependent diabetes, hypertension, and physical and role functioning. In the most recent 157 patients, our studies were extended to study the effects of the gastric bypass on mental health. The significant improvements in mental health indices that were observed 6 and 12 months after surgery eroded by the end of 2 years. This return of the mental health indices to the preoperative status, plus the late occurrence of 3 suicides and 2 deaths from alcohol abuse among the total 462 patients, suggest that long-term follow-up and continued emotional support are essential ingredients for successful bariatric surgery.     

Change in predicted 10-year and lifetime cardiovascular disease risk after Roux-en-Y gastric bypass

BackgroundLong-term changes in cardiovascular disease (CVD) risk after bariatric surgery are not well characterized.ObjectiveTo report sex-specific changes in CVD risk after Roux-en-Y gastric bypass surgery (RYGB).SettingObservational cohort study at ten hospitals throughout the United States.MethodsBetween 2006 and 2009, 1770 adults enrolled in a prospective cohort study underwent RYGB at 1 of 10 U.S. hospitals. Research assessments were conducted presurgery and annually postsurgery over 7 years. Sex specific–predicted 10-year and lifetime CVD risk were calculated using the Framingham10-year and lifetime risk scores, Framingham–body mass index, and atherosclerotic CVD scoring algorithms among participants with no history of CVD. Of 1566 eligible participants, 1234 (75.9%) with CVD risk determination pre- and postsurgery were included (1013 females, 221 males).ResultsBased on the Framingham10-year and lifetime risk scores, the percentage of females with predicted high (>20%) 10-year CVD risk declined from presurgery (6.5% [95% confidence interval: 6.7–7.5]) to 1 year postsurgery (1.0% [95% confidence interval: .8–1.2]; P < .001), then increased 1 to 7 years postsurgery (to 2.8% [95% confidence interval: 1.6–3.3]; P = .003), but was lower 7 years postsurgery versus presurgery (P < .001). Time trends for percentage of high-risk participants and mean CVD risk scores were similar for both sexes and other evaluated CVD risk scores. For example, among males mean lifetime atherosclerotic CVD score declined from presurgery to 1 year postsurgery, then increased 1 to 7 years postsurgery. However, there was a net decline from presurgery (P < .001).ConclusionAmong both females and males, predicted 10-year and lifetime CVD risk was substantially lower 7 years post RYGB than presurgery, suggesting RYGB surgery can lead to sustained improvements in short- and long-term CVD risk.     

Roux-en-Y gastric bypass decreases serum inflammatory markers and cardiovascular risk factors in obese diabetics

BackgroundObesity and type 2 diabetes mellitus are associated with elevated levels of inflammatory markers. This chronic inflammation is known to contribute to increased risk of cardiovascular disease in these populations. Laparoscopic Roux-en-Y gastric bypass is associated with a high rate of diabetes remission. We hypothesize that laparoscopic Roux-en-Y gastric bypass decreases systemic inflammatory markers and cardiovascular disease risk factors in obese diabetics.MethodsThis was a single-institution prospective cohort study of 61 obese patients with type 2 diabetes mellitus. A total of 30 patients underwent laparoscopic Roux-en-Y gastric bypass surgery, and 31 patients underwent standard medical therapy with diabetes support and education. Collected data included preoperative and postoperative inflammatory biomarkers and clinical parameters.ResultsTwelve months after undergoing laparoscopic Roux-en-Y gastric bypass, controlling for sex and age, there was a significant correlation between a change in interleukin-6 and a change in systolic blood pressure (Spearman r = 0.41, P = .03). Similarly, when sex and age were controlled for in the laparoscopic Roux-en-Y gastric bypass group, a statistically significant relationship remained between percent excess weight loss and change in interleukin-6 (P = .001).ConclusionA significant relationship exists between decreased systemic interleukin-6 levels and both excess weight loss and lowered systolic blood pressure after laparoscopic Roux-en-Y gastric bypass in obese patients with diabetes mellitus. These correlations may explain the decreased risk of cardiovascular disease after surgical weight reduction in this patient population.     

Early effects of gastric bypass on endothelial function, inflammation, and cardiovascular risk in obese patients

Background  

Obesity is associated with a chronic low-grade inflammatory state, insulin resistance, and endothelial dysfunction, all of which contribute to increased risk of cardiovascular disease. We hypothesized that gastric bypass would produce rapid improvements in endothelial function, reduce inflammation, and lead to a decrease in cardiovascular risk.     

Long-term cardiovascular risk and coronary events in morbidly obese patients treated with laparoscopic gastric banding

BackgroundLong-term studies reporting the effects of bariatric surgery on cardiovascular risk factors and events are scarce. The aim of this study was to analyze reduction of multiple cardiovascular risk factors and rates of coronary events in morbidly obese patients treated with bariatric surgery and with>10 years of follow-up.MethodsThis was a prospective uncontrolled study with laparoscopic adjustable gastric banding. Cardiovascular risk factors (fasting glucose, total cholesterol, HDL-C, triglycerides, blood pressure) have been previously determined both at surgery and 12–18 months after in 650 patients treated with laparoscopic adjustable gastric banding from 1993 to 1999. Cardiovascular risk status was again determined in 2010, and the rate of coronary events during long-term (>10 years) follow-up was collected.ResultsA total of 318 patients (58 men and 260 women) were retrieved. Age at surgery was 38.6±10.4 years. Body mass index was 46.7±7.2 kg/m². Follow-up was 12.7±1.5 years. Weight loss was 17.6%±15.7% of baseline weight at 12–18 months and 17.1%±14.8% at 12.7 years. A significant reduction in blood glucose, total cholesterol, triglycerides, and systolic and diastolic blood pressure was observed at the short-term evaluation and confirmed in the long term. HDL-C was unchanged at 12–18 months and significantly increased at 12.7 years. Five coronary events (1.6%) were recorded during long-term follow-up. The rate of observed events was compared with the rate of events expected according to baseline 10-year probability of myocardial infarction calculated with the Prospective Cardiovascular Munster study (PROCAM) score. Observed rate (1.6%) was slightly lower than the expected rate (2.0%± 4.9%).ConclusionsStable weight loss and significant improvement of cardiovascular risk profile were observed in morbidly obese patients 10 years after laparoscopic adjustable gastric banding.     

Effect of gastric bypass on gastric secretion.

Gastric bypass as a 90 per cent gastric exclusion operation was used in 393 patients with massive obesity to limit food intake. Stomal ulcer has occurred in 1.8 per cent of such patients or one ulcer per 140 man years of observation. The studies of indwelling fundic pH and of gastric acid secretion from the excluded stomach indicate that acid secretion is reduced after gastric bypass but that the acid, unbuffered by food in the excluded stomach, results in a lowered gastrin secretion after a meal. Thus, gastric bypass in inhibitory to acid secretion in most morbidly obese patients who do not have known acid peptic disease.     

A comparison of weight histories in women with class III vs. class I–II obesity

OBJECTIVE: To describe the weight histories of women with extreme or class III obesity (BMI >or= 40 kg/m2) in comparison with a sample of women with class I-II obesity (BMI < 40 kg/m2) and to provide reliability data for a clinical instrument that assesses weight history. RESEARCH METHODS AND PROCEDURES: Female patients (N = 149) with extreme obesity seeking bariatric surgery and 90 class I-II obese women seeking behavioral treatment completed the Weight and Lifestyle Inventory (WALI), a self-report instrument that assesses age of onset of obesity, maximum weight at different ages, family weight history, and weight changes related to pregnancy. Test-retest reliability data were obtained by administering the WALI to a subsample (n = 58) of class I-II obese participants at their initial visit and at another pretreatment visit 1 to 2 weeks later. RESULTS: Patients with extreme obesity had a significantly younger age of onset of obesity, were significantly heavier at all age ranges, reported significantly more weight gain with their first pregnancy, and had significantly heavier parents and siblings as compared with less obese patients. There were no significant differences between groups with respect to weight gain during second pregnancies or postpartum weight retention. Robust test-retest correlations were obtained for the weight history items on the WALI. DISCUSSION: Patients with extreme obesity report more indicators of a genetic predisposition to obesity as compared with less obese patients. The WALI appears to be a reliable instrument for the assessment of weight history in obese patients.     

Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity

OBJECTIVE: To identify the factors that increase mortality for either open or laparoscopic Roux-en-Y gastric bypass. SUMMARY BACKGROUND DATA: Perioperative mortality is the most feared outcome of bariatric surgery, reported to occur in between 0.5% and 1.5% of patients. METHODS: The bariatric database at Virginia Commonwealth University was queried for patients who had undergone either an open gastric bypass (O-GBP) or a laparoscopic gastric bypass (L-GBP). A multivariate logistic regression analysis to identify factors related to perioperative mortality was performed. Factors examined included age, gender, body mass index, preoperative weight, hypertension, diabetes mellitus, sleep apnea, obesity hypoventilation syndrome, venous stasis ulcers, intestinal leak, small bowel obstruction, and pulmonary embolus. RESULTS: Since 1992, more than 2000 patients had either an O-GBP (n = 1431) or a L-GBP (n = 580). Of the O-GBP, 547 patients had a proximal GBP (P-GBP) and 884 superobese (body mass index > 50 kg/m) patients had a long-limb GBP (LL-GBP). The differences in patient demographics, complications, and perioperative mortality rates between L-GBP and O-GBP and P-GBP and LL-GBP patients were examined. Overall, the independent risk factors associated with perioperative death included leak, pulmonary embolus, preoperative weight, and hypertension. CONCLUSIONS: The risk factors for perioperative death can be separated into patient characteristics and complications. The access method, open versus laparoscopic, was not independently predictive of death, but the operation type, proximal versus long limb, was predictive. The data do not suggest that superobese patients should not undergo surgery, as they are high risk for early death due to their body weight and comorbidities without surgery. Surgery should not be reserved as a desperate last measure for weight loss.     

Comparison of psychosocial status in treatment-seeking women with class III vs. class I–II obesity

OBJECTIVE: This study compared the psychosocial status and weight loss expectations of women with extreme (class III) obesity who sought bariatric surgery with those of women with class I-II obesity who enrolled in a research study on behavioral weight control. RESEARCH METHODS AND PROCEDURES: Before treatment, all participants completed the Beck Depression Inventory-II and the Weight and Lifestyle Inventory. This latter questionnaire assesses several domains including symptoms of depression and low self-esteem, history of psychiatric complications, current stressors, and weight loss expectations. RESULTS: Women with class III obesity, as compared with class I-II, reported significantly more symptoms of depression. Fully 25% of women in the former group appeared to have a significant mood disorder that would benefit from treatment. As compared with women with class I-II obesity, significantly more women with class III obesity also reported a history of psychiatric complications, which included physical and sexual abuse and greater stress related to their physical health and financial/legal matters. Both groups of women had unrealistic weight loss expectations. Those who sought surgery expected to lose 47.6 +/- 9.3% of initial weight, compared with 24.8 +/- 8.7% for those who enrolled in behavioral weight control. DISCUSSION: These findings suggest that women with extreme obesity who seek bariatric surgery should be screened for psychosocial complications. Those determined to have significant psychiatric distress should be referred for behavioral or pharmacological treatment to alleviate their suffering. Long-term studies are needed to provide definitive guidance concerning the relationship between preoperative psychopathology and the outcome of bariatric surgery.     

Jejunoileal bypass versus gastric bypass or gastroplasty in the operative treatment of obesity

A comparative study has been made of three methods for the operative treatment of obesity. Of my own cases, 235 underwent a jejunoiliac bypass procedure, and the results have been analyzed: operative lethality 2.1%; postoperative complications 21%. Of the patients whose residual ileum was quite short (about 45 cm), about 70% reached their ideal weight. Metabolic late complications were considerable (e.g., liver damage in 15%, electrolyte deficit in 12%, and arthritis in 10%). In the late observation time of 14 years, 14 patients died, 10 of them as a result of the operation. Three different stomach-bypass procedures are described. The collective statistics compiled on 1585 patients indicated 1.6% postoperative lethality and 22% postoperative complications. Of the total patients, 90% were very satisfied with the procedure and in only 5% was a weight gain recorded after 5 years. The latest procedure is gastroplasty according to the Gomez method: the first 200 cases show 0.5% postoperative lethality and postoperative complications in 18.5%. Although this procedure is technically simple, the late observation time is not yet adequate for a definitive comparison.

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Jejuno-ilealer Bypass, Magen-Bypass oder Magenplastik in der operativen Behandlung der Fettsucht

Zusammenfassung Dies ist eine vergleichende Studie dreier Verfahren für operative Behandlung der Fettsucht. Es werden 235 eigene Fälle mit jejunoilealem Bypass analysiert. Die Operationsletalität war 2,1%, postoperative Komplikationen kamen 21% vor. Nur bei Patienten mit wirklich kurzem Restileum (ca. 45 cm) erreichten 70% ihr Idealgewicht. Die metabolischen Spätkomplikationen waren beträchtlich (Leberschäden in 15%, Elektrolytdefizite in 12%, Arthritis 10% etc.). In der Nachbeobachtungszeit von 14 Jahren verstarben 14 Patienten, davon 10 an den Folgen der Operation. 3 verschiedene Magen-Umgehungsverfahren werden beschrieben. In einer Sammelstatistik von 1585 Patienten lag die postoperative Letalität bei 1,6%, die der postoperativen Komplikationen bei 22%. 90% der Patienten waren sehr zufrieden mit dem Eingriff und nur bei 5% war nach 5 Jahren erneute Gewichtszunahme zu verzeichnen. Das jüngste Verfahren, die Gastroplastik nach Gomez, wird anhand seiner ersten 200 Fälle durchleuchtet: 0,5% postoperative Letalität, postoperative Komplikationen in 18,5%. Die Nachbeobachtungszeit bei diesem technisch einfachen Verfahren reicht noch nicht für einen endgültigen Vergleich aus.

     

Validation of the obesity surgery mortality risk score in a multicenter study proves it stratifies mortality risk in patients undergoing gastric bypass for morbid obesity

BACKGROUND: A scoring system for clinical assessment of mortality risk has been previously proposed for bariatric surgery (Demaria EJ, Portenier D, Wolfe L, Surg Obes Relat Dis. 2007;3:34-40.). The Obesity Surgery Mortality Risk Score (OS-MRS) was developed from a single institution experience of 2075 patients. The current study provides multicenter validation of the value of the OS-MRS. The OS-MRS assigns 1 point to each of 5 preoperative variables, including body mass index>or=50 kg/m2, male gender, hypertension, known risk factors for pulmonary embolism (previous thromboembolism, preoperative vena cava filter, hypoventilation, pulmonary hypertension), and age>or=45 years. Patients with total score of 0 to 1 are classified as 'A' (lowest) risk group, score 2 to 3 as 'B' (intermediate) risk group, and score 4 to 5 as 'C' (high) risk group. METHODS: Prospectively-collected data from 4431 consecutive patients undergoing a primary gastric bypass at 4 bariatric programs recruited to validate the proposed system were analyzed to assess OS-MRS as a means of stratifying surgical mortality risk. RESULTS: There were 33 total deaths for an overall mortality for the validation cohort of 0.7% consistent with published standards. Mortality for 2164 class A patients was 0.2%, for 2142 class B patients was 1.1%, and for 125 class C patients was 2.4%. Mortality was significantly different between each of the class A, B, and C groupings (P<0.05, chi2). Mortality was 5-fold greater in the class B group than in class A. Only 6 patients with all 5 risk factors were identified. Class C patients (n=125, 3% of total cohort) were characterized by a 12-fold greater mortality than the lowest risk group (A) and a disproportionate 9% of all mortalities. CONCLUSION: The OS-MRS was found to stratify mortality risk in 4431 patients from 4 validation centers that were nonparticipants in the original defining cohort study. The score represents the first validated scoring system for risk stratification in bariatric surgery and is anticipated to aid informed consent discussions, guide surgical decision-making, and allow standardization of outcome comparisons between treatment centers.