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.
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.
Authors: Jeffrey I Mechanick; Robert F Kushner; Harvey J Sugerman; J Michael Gonzalez-Campoy; Maria L Collazo-Clavell; Safak Guven; Adam F Spitz; Caroline M Apovian; Edward H Livingston; Robert Brolin; David B Sarwer; Wendy A Anderson; John Dixon Journal: Surg Obes Relat Dis Date: 2008-08-19 Impact factor: 4.734
Authors: Steven H Belle; Paul D Berk; Anita P Courcoulas; David R Flum; Carolyn W Miles; James E Mitchell; Walter J Pories; Bruce M Wolfe; Susan Z Yanovski Journal: Surg Obes Relat Dis Date: 2007 Mar-Apr Impact factor: 4.734
Authors: Nicholas J Gargiulo; Frank J Veith; Evan C Lipsitz; William D Suggs; Takao Ohki; Elliot Goodman; Pratt Vemulapalli; Karen Gibbs; Julio Teixeira Journal: Ann Vasc Surg Date: 2007-09 Impact factor: 1.466
Authors: Basilios Papaziogas; Ioannis Koutelidakis; Apostolos Kabaroudis; Ioannis Galanis; George Paraskevas; George Vretzakis; Konstantinos Atmatzidis Journal: Hepatogastroenterology Date: 2007 Jul-Aug
Authors: Stavros Kakkos; George Kirkilesis; Joseph A Caprini; George Geroulakos; Andrew Nicolaides; Gerard Stansby; Daniel J Reddy Journal: Cochrane Database Syst Rev Date: 2022-01-28
Authors: Maria S Altieri; Jie Yang; Janos Hajagos; Konstantinos Spaniolas; Jihye Park; Antonios P Gasparis; Andrew T Bates; Salvatore Docimo; Mark Talamini; A Laurie Shroyer; Aurora D Pryor Journal: Surg Endosc Date: 2018-05-15 Impact factor: 4.584
Authors: Stavros K Kakkos; Joseph A Caprini; George Geroulakos; Andrew N Nicolaides; Gerard Stansby; Daniel J Reddy; Ioannis Ntouvas Journal: Cochrane Database Syst Rev Date: 2016-09-07