Surgery News - March 2008 - (Page 23) MARCH 2008 • SURGERY NEWS VASCULAR Hybrid Aortic Repair: Effective, but Expensive BY BRUCE JANCIN Else vier Global Medical Ne ws C O L O R A D O S P R I N G S — Combined aortic debranching and thoracoabdominal aortic endovascular repair is a less invasive alternative to open surgical repair of complex aortic aneurysms that provides better outcomes even in older, sicker patients. That’s the good news about the innovative hybrid procedure. The bad news is that direct hospital costs are higher, and reimbursement is lower than for conventional open surgery. As a result, the hospital takes a 34% net loss on each patient who undergoes the hybrid procedure, Dr. Erin H. Murphy said at the annual meeting of the Western Surgical Association. In contrast, open surgical repair provides a net 6% profit, added Dr. Murphy of the University of Texas Southwestern Medical Center, Dallas. Multiple small series, the largest involving 15-30 patients, have demonstrated that the hybrid procedure results in low rates of operative mortality, spinal cord isReimbursement by chemia, and perioperative morbidity. both Medicare In contrast, open and private repair is associated insurers was markedly less for with 10%-20% operative mortality hybrid repair. rates, renal failure DR. MURPHY in 15%-30% of cases, and other morbidities. However, there had been no prior hospital cost analyses. To remedy this, Dr. Murphy reviewed the records of 27 Southwestern patients with aortic pathology involving branch vessels. Of those, 15 underwent hybrid repair because they were at high risk for open repair and had anatomy unsuited for endografting alone. The other 12 underwent conventional open repair. The two groups were similar in terms of location of aortic pathology. The hybrid repair was performed in a single session, although at some other centers it is done as a two-stage procedure. The hybrid procedure is used in patients with complex aneurysms of the proximal descending thoracic aorta and/or distal aortic arch with branch vessel involvement. Aortic debranching and placement of an elephant graft are performed surgically through a sternotomy. Aneurysm exclusion is then completed by means of thoracoabdominal endovascular repair via peripheral access of instruments and devices. The patients who had hybrid repair averaged 73 years of age, versus 58 years for the open-repair group. Six patients in the hybrid-repair group were known to have significant coronary artery disease, as was one in the open-repair group. Nonetheless, the hybrid-repair group had significantly less intraoperative blood loss, fewer transfusions, lower rates of major in-hospital complications, fewer days on the mechanical ventilator, and less time in the ICU. Data supplied by the hospital finance department showed that the average total direct and indirect in-hospital cost of a hybrid repair was just under $82,000, compared with $76,000 for open repair. But reimbursement by both Medicare and private insurers was markedly less for hybrid repair, with a resultant negative 34% mean cost margin. “The Gore TAG endoprostheses cost about $10,000 apiece. If you put in one, you’re kind of ahead of the game. With two you’ve got a small loss, and with three you’re clearly at a negative. We’re all hoping the cost of grafts will come down,” Dr. Murphy said. Discussant Dr. Bruce L. Gewertz said he was impressed by the hybrid procedure. “Speaking now as an elder and someone who does predominantly operative surgery, I’ve calculated I’m losing one operation every 3 years. With 15 more years of projected work, it should just about work out that by the time I retire there’ll be nothing else for me to do,” quipped Dr. Gewertz, chairman of the department of surgery and surgeon-in-chief at CedarsSinai Medical Center, Los Angeles, and an ACS Fellow. Audience member Dr. Laurens R. Pickard, an ACS Fellow at Baylor College of Medicine, Houston, observed that the total costs associated with hybrid repair would have been far greater had Dr. Murphy included the expense of posthospital follow-up CT surveillance of the endografts, along with treatment of endoleaks. Dr. Murphy replied that those costs are showing a downward trend. Routine CT surveillance is giving way to ultrasound, and it lately has become apparent that not all endoleaks require treatment, he said. ■ 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 an http://www.wyeth.com http://www.wyeth.com
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