Background: Anticoagulation, the use of sequential compression devices on the lower extremities perioperatively, and early ambulation are thought to reduce the incidence of venous thromboembolism (VTE) postoperatively and are recommended to reduce VTE risk. However, the evidence on which this recommendation has been based is not particularly strong. We have demonstrated that even a large, multicenter cohort with carefully collected prospective data is inadequate to provide sufficient evidence to support, or refute, this recommendation. Methods: Longitudinal Assessment of Bariatric Surgery participants from 10 centers in the United States who underwent their first bariatric surgery between March 2005 and December 2007 constituted the study group. We examined the ability to address the question of whether anticoagulation therapy, in addition to sequential compression, reduces the 30-day incidence of VTE or death sufficiently to recommend the use of prophylactic anticoagulation, a therapy that is not without risk. Results: Of 4416 patients, 396 (9.0%) received sequential compression alone, and 4020 also received anticoagulation therapy. The incidence of VTE within 30 days of surgery was low (.25% among those receiving sequential compression alone and.47% when anticoagulation therapy was added), and the 30-day incidence of death was also low (.25% versus.34%, respectively, P =.76, for sequential compression alone versus sequential compression plus anticoagulation therapy). Estimates of the number of cases required to address the question of whether a difference exists in the outcome related to VTE chemoprophylaxis or whether the outcome rates are equivalent have ranged from 13,680 to <35,760 patients, depending on whether superiority or equivalence was being analyzed. Conclusion: Sufficient evidence from a clinical trial study to determine whether prophylactic anticoagulation added to compression devices further prevents VTE is not available, and such a trial is likely to be impractical. The data presented are insufficient to make a final recommendation concerning prophylactic treatment to prevent VTE in the 30 days after bariatric surgery.
|Number of pages
|Surgery for Obesity and Related Diseases
|Published - Nov 2012
Bibliographical noteFunding Information:
M. Gagner, F. Selzer, G. Strain, M. Bessler, A. P. Courcoulas, G. Dakin, W. B Inabnet, J. Mitchell, and A. Pomp had a subcontract for the Longitudinal Assessment of Bariatric Surgery from the National Institute of Diabetes and Digestive and Kidney Diseases. In addition, M. Gagner has received speaker honoraria and travel grants from Covidien , travel grants, speaker honoraria, and unrestricted research grants from Ethicon Endosurgery , and honoraria and travel grants from Gore ; M. Bessler has performed consulting for Bard, Covidien, Ethicon, and GI Dynamics and received research support from Olympus, Storz, and USGI; A. P. Courcoulas has been a consultant to GNC, Inc.; W. B Inabnet has been on the Clinical Advisory Committee and received research grant and fellowship support from Covidien , has been a consultant to the Surgical Review Corporation, and has been a bariatric site inspector for the American College of Surgeons; and A. Pomp has received honoraria (as a consultant), travel grants, and research grants from Covidien , Ethicon , and W.L. Gore & Associates .
This clinical study was a cooperative agreement funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): grant DCC-U01 DK066557 , grant U01-DK66667 to Columbia (in collaboration with Cornell University Medical Center CTSC, grant UL1-RR024996 ); grant U01-DK66568 to University of Washington (in collaboration with CTRC, grant M01RR-00037 ); grant U01-DK66471 to Neuropsychiatric Research Institute; grant U01-DK66526 to East Carolina University; grant U01-DK66585 to University of Pittsburgh Medical Center (in collaboration with CTRC, grant UL1-RR024153 ); and grant U01-DK66555 to Oregon Health and Science University.
- Bariatric surgery
- Deep vein thrombosis
- Pulmonary emboli
- Sequential compression
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