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.
"Recent studies have shown that venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a significant and frequent complication after bariatric surgery [1–3]. Reported rates of post-operative DVT and/or PE range from 1 to 15 % despite prophylaxis [4–6], and about 50 % of deaths occurring in bariatric patients are attributed to a fatal PE . Therefore, prevention of VTE is crucial in this clinical setting, and various regimens of low molecular weight heparin (LMWH) are used for peri-operative thromboprophylaxis [8–14]. "
[Show abstract][Hide abstract] 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; 24(2). DOI:10.1007/s11695-013-1105-x · 3.75 Impact Factor
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