Evidence of thromboembolism prophylaxis in bariatric surgery-results of a quality assurance trial in bariatric surgery in Germany from 2005 to 2007 and review of the literature.
ABSTRACT Since January 1st, 2005, the current situation for bariatric surgery has been examined by means of a voluntary quality assurance study in Germany with a multicenter design in which 38 hospitals and surgical departments participated. The data are registered in cooperation with the Institute of Quality Assurance in Surgery at the Otto-von-Guericke University of Magdeburg (Germany).
Data describing peri-interventional characteristics were prospectively documented in an internet online data registry. All primary bariatric procedures performed since January 1st, 2005, were registered. In addition, reoperations in patients who had previously undergone primary surgical intervention were included. As a representative excerpt from the overall prospective multicenter observational study on obesity surgery, data on the type, regimen, and time course of deep venous thrombosis (DVT) prophylaxis were documented. From the number and spectrum of complications, the incidences of clinically manifest DVT or pulmonary embolism (PE) were derived during the in-hospital course and follow-up in conjunction with the type of surgical procedure and body mass index (BMI).
Overall, 3,122 bariatric procedures were performed at 38 German hospitals between January 2005 and December 2007. These procedures were subdivided into 2,869 primary operations and 253 revisions (sex ratio, male to female = 25.6:74.4%). The average BMI of all patients was 48.5 kg/m(2) in 2005, 48.4 kg/m(2) in 2006, and 48.0 kg/m(2) in 2007. In 2005 and 2006, gastric banding (GB) was the most commonly performed operation, followed by Roux-en-Y gastric bypass (RYGBP). In 2007, RYGBP was carried out in 42.1% of all bariatric procedures. Interestingly, the incidence of deep venous thrombosis (DVT) was only 0.06%, whereas PE occurred in 0.06% of patients only after hospital discharge. The DVT prophylaxis protocol used has been changed for the last 2 years: the majority of patients with a BMI above 50 kg/m(2) received low-molecular-weight heparin twice a day.
In Germany, a trend from GB to sleeve gastrectomy (SG) and malabsorptive approach has been evaluated. This trend is associated with differences of the DVT prophylaxis regimen in the profile of bariatric surgical patients depending on BMI and the type of bariatric procedure. Despite the low incidence of DVT and pulmonary embolism (PE) detected, there is a lack of evidence on a reasonable regimen for sufficient DVT prophylaxis in bariatric surgery; instead, there are only recommendations from the guidelines and statements of a specific medical society. Therefore, prospective studies are necessary to determine the optimal DVT prophylaxis for bariatric surgical patients as well as obese patients undergoing surgery.
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ABSTRACT: The optimal dose of low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. The aim of this multicentre, open-label, pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery. Patients were randomised to receive 4,250 IU/day (group A) or 6,400 IU/day (group B) of parnaparin s.c. for 7-11 days. Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis, symptomatic pulmonary embolism and death from any cause during treatment. The primary safety endpoint was major and clinically relevant non-major bleeding. A total of 258 patients underwent randomization; 8 subjects were excluded following the safety analysis. One hundred thirty-one patients [106 females; mean age, 40.3 years (standard deviation (SD) ±9.6); mean body mass index (BMI), 44.6 kg/m(2) (SD ±5.4)] were assigned to group A and 119 patients [93 females; mean age, 41.5 years (SD ±9.9); mean BMI, 44.2 kg/m(2) (SD ±5.4)] were assigned to group B. The rate of the primary efficacy outcome was 1.5 % (two cases; 95 % confidence interval (CI), 0.2-6.0 %) in group A as compared with 0.8 % (one case; 95 % CI, 0.4-5.3 %) in group B (p = ns). The composite incidence of major bleeding and clinically relevant non-major bleeding was 6.1 % (eight cases; 95 % CI, 2.9-12.1 %) in group A and 5.0 % (six cases; 95 % CI, 2.1-11.1 %) in group B (p = ns). A parnaparin dose of 4,250 IU/day seems suitable for VTE prevention in patients undergoing bariatric surgery.Obesity Surgery 10/2013; · 3.74 Impact Factor
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ABSTRACT: Abstract Background: Venous thromboembolism is the most common postoperative medical complication after bariatric surgery. Mortality associated with thromboembolic processes can reach up to 50%-75%. The aim of this study was to determine the incidence of deep vein thrombosis (DVT) and portal-splenic-mesenteric vein thrombosis (PSMVT) in our population undergoing laparoscopic sleeve gastrectomy (LSG) as the bariatric technique, with an anti-thromboembolic dosage scheme of 0.5 mg/kg/day 12 hours preoperatively and maintained during 30 days postoperatively. Patients and Methods: A prospective observational study was performed, including 100 consecutive patients undergoing LSG between October 2007 and September 2013. To determine the incidence of DVT and PSMVT, all patients undergo contrast-enhanced abdominal computed tomography (CT) and Doppler ultrasonography (US) of both lower limbs on the third postoperative month, whether they were asymptomatic or symptomatic. Results: Contrast-enhanced CT showed 1 case of PSMVT (1%). Two patients presented DVT in the right leg (2%). All the cases were asymptomatic. Conclusions: The incidence of PSMVT and DVT after LSG with a prophylactic low-molecular-weight heparin dose of 0.5 mg/kg/day and maintained during 30 days postoperatively is 1% and 2%, respectively. According to these results, a postoperative screening with Doppler US and/or contrast-enhanced CT seems to be unnecessary.Journal of Laparoendoscopic & Advanced Surgical Techniques 07/2014; · 1.19 Impact Factor
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ABSTRACT: Studies suggest that postoperative complications are a risk factor for venous thromboembolism (VTE) after bariatric surgery. Knowledge of factors associated with a higher risk of VTE after bariatric surgery may be essential to select patients who may benefit from either prolonged or intensified thrombosis prophylaxis. The aim of this study is to determine the relationship between postoperative complications and VTE after bariatric surgery and other classical risk factors. A retrospective multicenter case-control study was performed in patients who had bariatric surgery between January 2008 and September 2011. VTE until 6 months after surgery was registered, and patients were contacted to ascertain the results. For every case of VTE after surgery, 6 control patients were selected who were matched for gender, age, participating center and type of surgery. Risk factors for VTE before and after surgery and postoperative complications were registered. A total of 2,064 surgeries were included. In 12 patients, VTE occurred within 6 months after bariatric surgery (incidence 0.58 %, 95 % confidence interval (CI) = 0.25-0.93). There was a strong association of complications after surgery (cases 91.7 %, controls 15.3 %, odds ratio (OR) 61.0; 95 % CI = 7.1-521.3) or intensive care admission (cases 50.0 %, controls 11.1 %, OR = 8.0; 95 % CI = 2.1-30.8) with VTE. The majority of postoperative complications were anastomotic leak, abdominal abscess, and infection. We could not detect an association between classical thrombosis risk factors and postoperative VTE. The incidence of VTE is low after bariatric surgery using thrombosis prophylaxis. However, there is a strong association between postoperative complications and VTE. These patients may benefit from more intensive thrombosis prophylaxis.Obesity Surgery 04/2014; · 3.74 Impact Factor