Introduction http:/www.surgeongeneral.gov/topics/obesity http://www.asbs.org 1 2 3 This report is a multivariate analysis of preoperative mortality and morbidity in 1,000 consecutive open RYGBs performed over a 5-year period by a single surgeon (LF) in at a single institution. Materials and Methods Bariatric Surgery Program Clinical Protocol and Surgical Technique 4 12 1 12 1 Clinical Data and Data Analysis Results 1 2 Table 1 Demographic Characteristics by Sex and Race   Women Men Total p Age (years) 38 ± 1.0 (15–73) 40 ± 11.9 (15–65) 38 ± 11.17 (15–73) 0.064 Weight (kg) 134 ± 27 (84–263) 170 ± 43 (81–345) 139 ± 33 (82–345) <0.01 2 51 ± 10 (35–1,000) 55 ± 13 (24–116) 51 ± 10 (24–116) <0.01 Caucasian (28%) 238/853 (53%) 78/147 32% <0.01 African–American (30%) 253/853 (20%) 29/147 28% 0.01 Hispanic (42%)358/853 (27%)40/147 40% <0.01 Other (0.5%) 4/853 (0%) 0/147 0.4% 0.41 Table 2 Prevalence of Obesity-Related Comorbid Conditions by Sex   N N Total (%) p Type II diabetes mellitus 177 (21) 54 (37) 23 <0.01 Hypertension 310 (36) 79 (54) 39 <0.01 CAD/CHF 29 (3) 26 (18) 6 <0.01 Dyslipidemia 376 (44) 80 (54) 47 0.02 Sleep apnea 172 (20) 63 (43) 24 <0.01 Asthma 135 (16) 16 (11) 15 0.12 Dyspnea on exertion 811 (95) 127 (86) 48 <0.01 GERD 513 (60) 77 (52) 59 0.08 Osteoarthritis 791 (93) 126 (87) 92 <0.01 Urinary stress incontinence 430/(50) 5 (3) 44 <0.01 Irregular menses 276 (32) NA 32 NA CAD/CHF GERD The most common comorbidites encountered were dyspnea on exertion (94%), joint pain/arthritis (92%), and gastroesophageal reflux disease (59%). The comorbidites typically associated with systemic disease included hypertension (HTN, 39%), obstructive sleep apnea (SA, 24%), dyslipidemia (46%), and asthma (15%). Approximately 23% of the patient population suffered from type II diabetes mellitus (DM). At time of initial evaluation, 13.0% of this diabetic patient subset had a prior history of insulin-dependent DM, 57.6% had noninsulin dependent DM, and 23% had a previous diagnosis of DM intermittently controlled on diet or were newly diagnosed with DM during their preoperative evaluation. Six percent of the patient population had angiographically documented histories of coronary artery disease (CAD) but were deemed suitable risk by their respective specialists. Procedures and Duration of Hospital Stay Complications 3 Table 3 Incidence of Complications after RYGB Complication N N Total (%) p Systemic complications Prolonged intubation 3 (0.6) 8 (1.5) 1.1 0.16 (NS) Deep venous thrombosis 0 (0) 2 (0.4) 0.2 NS Pulmonary embolism 0 (0) 3 (0.6) 0.3 NS MI/fatal arrhythmia 1 (0.2) 1 (0.2) 0.2 NS Technical complications Incisional hernia 10 (2.1) 25 (4.8) 3.5 0.019 Intestinal obstruction 10 (2.1) 9 (1.7) 1.9 NS Leak 7 (1.5) 9 (1.9) 1.6 NS Dehiscence 2 (0.4) 2 (0.4) 0.4 NS GI bleeding requiring transfusion 3 (0.6) 6 (1.2) 0.9 NS Anastomotic ulcer 2 (0.4) 0 (0) 0.2 NS Anastomotic Stricture 6 (1.2) 2 (0.4) 0.8 NS Death 4 (0.8) 11 (2.1) 1.5 .03 Deaths N N p 3 4 Table 4 Causes of Early and Late Deaths Related to BMI Cause of death N N  BMI < 50 BMI ≥ 50 BMI < 50 BMI ≥ 50 MI/arrhythmia 0 2 0 0 Pulmonary/PE 0 1 0 0 0 1 2 1 2 0 0 1 0 0 MSOF cause unknown 1 1 0 0 Bleeding complications 1 2 0 0 PE MSOF p p p p p 5 Table 5 Logistic Regression Evaluation of Patient Comorbidity as Predictors of Mortality   p Relative Risk 95% Confidence Interval Age 0.042 1.059 1.002–1.120 BMI 0.130 1.025 0.993–1.058 Female 0.612 0.729 0.215–2.474 DM 0.852 0.889 0.259–3.054 HTN 0.257 2.085 0.585–7.438 CAD 0.001 7.446 2.195–25.258 Dyslipidemia 0.099 0.359 0.106–1.211 Asthma 0.070 3.065 0.913–10.293 SA 0.033 3.342 1.104–10.115 SOB 0.693 0.644 0.073–5.725 2 p 2 p p p p p p p p Discussion The tremendous growth of bariatric surgery over the past several years has spawned much interest in its complications and mortality, first in the media, but most recently in the public health arena as well. Health and malpractice insurance carriers as well as governmental agencies and professional societies are evaluating the risks of bariatric surgery and the surgeons that perform it. In several states, insurance companies have stopped covering bariatric surgery at the same time that the Centers for Medicare and Medicaid Services have approved coverage for them. Several malpractice carriers have stopped issuing policies for surgeons performing bariatric procedures while others are categorizing bariatric surgery as a high-risk subspecialty area, similar to obstetrics and neurosurgery, and increasing premiums accordingly. In each of these instances, the overriding fear or consideration appears to be that the risks associated with bariatric surgery are excessively high. 1 5 9 5 6 8 9 10 2 3 11 2 2 p 3 11 2 Multisystem organ failure accounted for 11 deaths in our series (73%). In six patients, this resulted from leaks or perforations; in one it followed a bowel obstruction, in two it followed postoperative hemorrhage and in two patients, the cause was never determined. In each of these instances, the complication was identified early and appropriate treatment and supportive care instituted. In four of the patients, the clinical course of SIRS and MSOF was characterized by extremely high temperatures (>105°F), with no apparent source ever identified. To our knowledge, this “syndrome” has not been reported, but may be due to the fact that the enormous adipose tissue stores in these patients may act as a “metabolic sink”, releasing cytokines and other mediators and perpetuating this extreme systemic inflammatory response. Two of the deaths were due to fatal arrhythmias, both in patients with known CAD, who were extensively evaluated preoperatively. The death due to pulmonary embolism occurred after discharge, even though the patient received prophylaxis with both heparin and pneumatic compression stockings in the hospital. The remaining death due to exsanguination was clearly preventable. Although males were significantly heavier and had higher BMIs than women, sex was not an independent predictor of morbidity. However, the presence of angiographically documented coronary artery disease was particularly ominous in men. Males with angiographically demonstrated CAD were 30 times more likely to die. In women, predictors of death included age and SA, but not CAD. With respect to race, Caucasian males with BMI > 50 and CAD were most likely to die, whereas SA was a predictor in African–American men. There were no predictors in Hispanics. Despite the increased mortality in Caucasian males with CAD, these patients were not candidates for cardiac revascularization and extreme weight loss was the only intervention thought to make a beneficial health impact. 2 3 11 2 12 13 9 14 15 Conclusion RYGB can be performed with acceptable perioperative morbidity in patients over a wide range of BMIs. Patients with BMI ≥ 50 have a higher morality for both initial operations and after reexploration. Age, coronary artery disease, and obstructive sleep apnea correlate with perioperative mortality. These three comorbidities were more prevalent in these patients and may contribute to this finding.