Surgery News - October 2008 - (Page 19)

OCTOBER 2008 • SURGERY NEWS GENERAL SURGERY Bariatric Surgery: Risky but Beneficial for Disabled B Y J E F F E VA N S Else vier Global Medical Ne ws N A T I O N A L H A R B O R , M D . — Disabled Medicare patients who undergo bariatric surgery may have higher operative mortality and a greater rate of complications than those outside of the federal program, but these risks appear to be counterbalanced by a substantial improvement in health, according to a singlecenter, retrospective study. Perceptions of the risks and benefits of bariatric surgery in Medicare patients (or older patients in general) have tipped back and forth in various studies since 2004, when a report found that patients older than 55 years had elevated 30-day mortality from the procedures, especially at lowvolume centers (Ann. Surg. 2004;240:586- (pickwickian) syndrome. Differences in the prevalence of comorbidities were even more pronounced in 72 men with Medicare coverage than in 576 men not covered by Medicare, according to Dr. Maher. Among all patients, those with Medicare coverage lost a significantly lower percentage of excess weight than did those who were not covered by Medicare (60% vs. 66%). While hypertension resolved more often among non-Medicare patients than among Medicare patients (65% vs. 49%, respectively), diabetes resolved at similar rates between the groups (77% vs. 65%, respectively). Men in both groups lost a similar percentage of excess weight, and diabetes resolved at similar rates (30% for Medicare vs. 23% for non-Medicare). But hypertension was resolved in 56% of men with Medicare coverage, compared with 30% of men not covered by Medicare, a significant difference. Mortality at 30 days was significantly higher among Medicare patients than among non-Medicare patients (2.5% vs. 0.8%). There was an even greater disparity in mortality between male Medicare patients and male non-Medicare patients (5.6% vs. 1.5%). Of the 27 Medicare patients not on disability, no one older than 65 years died. Compared with non-Medicare patients, those who were covered had a slightly higher rate of anastomotic leak but a lower rate of pulmonary embolism, possibly because they had a higher rate of preoperative insertion of inferior vena cava filters, Dr. Maher said. ■ HYPERTENSION WAS RESOLVED IN 56% OF MEN WITH MEDICARE COVERAGE, VERSUS 30% OF MEN NOT COVERED BY MEDICARE, A SIGNIFICANT DIFFERENCE. 93), said Dr. James W. Maher of the division of general surgery at Virginia Commonwealth University (VCU), Richmond. At the annual meeting of the American Society for Metabolic and Bariatric Surgery, Dr. Maher reviewed the results of bariatric procedures performed at VCU during 1981-2006. Prior to 1999, most bariatric procedures at VCU consisted of open Roux-en-Y gastric bypass (RYGB) or vertical banded gastroplasty. Since then, the university’s surgeons have performed mostly laparoscopic RYGB and a small number of laparoscopic adjustable gastric banding procedures. Dr. Maher and his coinvestigators compared the outcomes of 282 Medicare patients with those of 3,169 non-Medicare patients. All but 27 of 282 Medicare patients were on disability. Of the 282 Medicare patients, 175 had received open RYGB and 107 had received laparoscopic RYGB. Compared with non-Medicare patients at baseline, Medicare patients had a significantly higher mean age and mean body mass index, as well as significantly higher rates of hypertension, diabetes, obstructive sleep apnea, and obesity-hypoventilation INDEX OF ADVERTISERS Adolor Corporation Entereg Cardinal Health, Inc. ChloraPrep Ethicon Endo-Surgery, Inc. Echelon Flex General Scientific Corporation SurgiTel Surgi-Cam Surgical Hospitalists Corporate Wyeth Pharmaceuticals Inc. Tygacil 2-3 5 11 9 8 19-20 TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline. (See PRECAUTIONS, Pregnancy.) The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS General Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. (See ADVERSE REACTIONS.) In Phase 3 cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) vs the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. The safety and efficacy of TYGACIL in patients with hospital acquired pneumonia have not been established. In a study of patients with hospital acquired pneumonia, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 15/122 [12.3%]) than the comparator. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs including TYGACIL should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYGACIL is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TYGACIL or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Drug Interactions Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions in full prescribing information.) Concurrent use of antib

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Surgery News - October 2008 Contents Call to Action Issued to Support DVT, PE Prevention Protocol Changes May Increase Donor Organs CMS Targets 2011 for Switch to ICD-10 Opinion: Election 2008 The 20/20 Vision: Children's Health News From the College: Survival Strategy General Surgery: Innovations

Surgery News - October 2008

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