What are the current dosing recommendations for post-operative DVT prophylaxis in bariatric surgery patients? Are there any risk assessment or stratification tools available?

Comment by InpharmD Researcher

Recommendations vary with no clear concensus. The 2022 ASMBS guidelines for post-operative DVT prophylaxis in bariatric surgery patients favor a BMI-stratified dosing strategy, typically using low-molecular-weight heparin (LMWH) such as enoxaparin 40 mg every 12 hours for patients with a BMI ≤50 kg/m² and 60 mg every 12 hours for those with a BMI >50 kg/m², often extended for 10-14 days after discharge. For risk stratification, the validated Caprini Risk Assessment Model is frequently used to classify patients, with nearly all bariatric patients considered high or highest risk. While evidence is growing for the use of direct oral anticoagulants (DOACs) like rivaroxaban, LMWH remains the standard of care, and monitoring of anti-Xa levels may be considered for high-risk patients or those with extreme obesity to ensure therapeutic efficacy.

bariatric surgery post-operative DVT prophylaxis UFH LMWH DOAC assessment

Background

The 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) issued an updated position statement on perioperative venous thromboembolism (VTE) prophylaxis in bariatric surgery. The panel highlighted the ongoing lack of high-quality evidence concerning the safety, effectiveness, dosing, and duration of pharmacologic thromboprophylaxis during the peri-operative period. The complexity of dosage and timing further complicate the formulation of guidelines due to substantial variations. Pharmacoprophylaxis has not been extensively studied within the obese population, leading to uncertainties about the pharmacokinetics of these agents. Current recommendations advocate for BMI-stratified dosing, typically using low-molecular-weight-heparin (LMWH) 40 mg every 12 hours for patients with a BMI ≤50 kg/m² and a higher dose of 60 mg every 12 hours for those with a BMI >50 kg/m². This extended high-dose regimen for 10 to 14 days post-discharge has been shown to be safe without an increased risk of clinically significant bleeding. However, a significant concern noted is the potential inadequacy of standard fixed dosing, particularly in patients with severe obesity. Anti-Xa level monitoring is increasingly recognized as an important tool to ensure therapeutic efficacy. Studies cited show that a substantial proportion of patients (e.g., 21-31% in one study) did not reach the target prophylactic anti-Xa range (generally accepted as 0.2 to 0.4 IU/mL at peak) with standard fixed doses, necessitating individual dose adjustments. This monitoring is especially recommended for higher-risk patients, such as those with very high body weight (e.g., >150 kg) or higher lean body mass, who are on extended prophylaxis, as pharmacokinetics can be variable. Currently, there is no consensus or robust data regarding the optimal choice, dosing regimen, and duration of pharmacoprophylaxis after bariatric surgery. While conflicting data exist in the literature concerning the preferred type of pharmacoprophylaxis, various strategies involving single-agent and combined therapies of unfractionated heparin (UFH) and LMWH have been proposed. [1]

A 2022 systemic review and meta-analysis (N= 15) summarized studies evaluating the use of VTE prophylactic regimens to determine optimal dosing, duration, and agents of use. Both LMWH and fondaparinux may be effective in reducing VTE risk without increasing major bleeding or mortality risk (odds ratio [OR] 1.02; 95% confidence interval [CI] 0.14 to 7.39), but supporting evidence for this claim was rated low-quality. Pooled estimates suggest augmented LMWH dosing may both increase bleeding in comparison to standard dosing (OR 3.03; 95% CI 0.38 to 23.96) and show no added benefit in reducing VTE incidence (OR 0.57; 95% CI 0.07 to 4.39). Based on the incidence of post-surgery VTE events following discharge in observational studies, extended prophylaxis may show merit in patients who exhibit a higher VTE risk, but there is insufficient high-quality data to support this observation. There was no evidence regarding the efficacy of oral anticoagulants as peri-operative pharmacoprophylaxis in bariatric surgery. [2]

A review conducted in 2020 outlined an approach to preventing VTE after surgery. This review examined the assessment of postoperative VTE and bleeding risks in patients, as well as the delicate balance required to create an effective VTE prophylaxis plan. The appropriate dosing of heparin for obese patients remains uncertain. While therapeutic heparin dosage is typically determined based on a patient's total body weight, it is not as clear whether the standard prophylactic heparin doses offer adequate VTE protection for obese individuals. In bariatric surgery, research has suggested that higher doses of LMWH or low-dose UFH could slightly improve effectiveness in patients with significant obesity without a notable rise in bleeding risks. A summary of VTE prophylaxis recommendations following bariatric surgery can be found in Table 1. [3]

A 2014 literature review analyzed the appropriate enoxaparin dose for VTE prophylaxis in patients with extreme obesity by evaluating eight studies, six of which focused on bariatric surgery patients. The studies assessed fixed-dose regimens ranging from 30-60 mg subcutaneously (SQ) every 12 hours, as well as weight-based dosing strategies, including 0.5 mg/kg/day. Three investigations prioritized the incidence of VTE as the primary endpoint, while the others concentrated on achieving optimal anti-Xa levels. Findings indicated that higher-than-standard enoxaparin doses were necessary to attain target anti-Xa levels more consistently. Notably, a 2008 prospective, nonrandomized study further compared 40 mg and 60 mg SQ every 12 hours, demonstrating that the higher dose resulted in greater attainment of therapeutic anti-Xa levels (0.43 U/mL vs. 0.21 U/mL; p<0.001), though major bleeding events were uncommon. Additionally, another study observed a population of patients with a BMI >50 kg/m2 undergoing bariatric surgery for their therapeutic levels of anti-Xa after three doses of 60 mg enoxaparin SQ given every 12 hours. Four hours after the third dose, 69% of patients achieved the desired therapeutic anti-Xa levels, compared to 79% of patients with a BMI ≤50 kg/m2 who received 40 mg enoxaparin. When the VTE incidence and bleeding risk were assessed, only one patient had a confirmed deep vein thrombosis (DVT) after discontinuation of enoxaparin, and five major bleeding incidences were recorded. However, all events, except one bleeding incident were from the 40 mg cohort, causing authors to question whether enoxaparin was truly the cause of bleeding. Across all studies, enoxaparin doses exceeding conventional regimens were more frequently associated with optimal anti-Xa levels, with a potential reduction in VTE risk, particularly for bariatric surgery patients, although further large-scale, randomized trials are warranted to refine dosing recommendations in this population. [4]

Another 2014 systematic review and meta-analysis was conducted to determine whether a weight-based thromboprophylactic dosing regimen of heparin products is safe and effective in the post-operative period for obese patients undergoing bariatric surgery. Enoxaparin was used in three studies with a dosing regimen of enoxaparin 30 mg q12h, enoxaparin 40 mg q12h, or enoxaparin 60 mg q12h. Patients receiving weight-adjusted prophylactic doses of heparin products had an in-hospital rate of VTE of 0.54% (95% CI 0.2 to 1.0%) compared to 2.0% (95% CI 0.1 to 6.4%) in patients receiving fixed doses. Of all patients included in the study, the highest incidence of VTE was seen in those receiving a fixed dose of enoxaparin 30 mg q12h (Table 2). Rates of major bleeding were similar for patients receiving weight-adjusted dosing and fixed-dosing (1.6% vs 2.3%). Authors concluded that weight-adjusted dose for prophylaxis of VTE after bariatric surgery showed a non-significant trend to a lower rate of inpatient VTE complications without an increased risk of major bleeding. [5]

A 2025 review provided a summary of recent guidelines recommendations regarding VTE prophylaxis in bariatric surgery (see Table 2). Furthermore, a short discussion was presented regarding the role of direct oral anticoagulants (DOACs) in the post-operative setting. Rivaroxaban has been considered due to its oral dosing and pharmacokinetic studies showing stability in obesity. A 2023 RCT found a 7-day course of rivaroxaban 10 mg daily was effective. However, concerns about potential post-surgical absorption changes lead current guidelines to still favor LMWH for high-risk patients, and the application of DOACs in Asian populations requires specific study due to lower average body weight and a higher genetic risk of bleeding complications. [6]

A 2025 meta-analysis of seven studies concluded that DOACs are a safe and effective option for post-operative thromboprophylaxis in bariatric surgery patients. The pooled analysis found a low incidence of thrombotic events (0.23%), major bleeding (0.33%), and minor bleeding (1.27%), with rates that appeared favorable compared to cited data on enoxaparin. Regarding dosing, the included studies primarily evaluated regimens of rivaroxaban 10 mg once daily (for 7 to 30 days post-discharge) and apixaban (at prophylactic doses, typically 2.5 mg twice daily), when dosing was mentioned in the study. However, the analysis could not definitively establish a single optimal dose or duration, as protocols varied. The authors highlight that while pharmacokinetic studies support the stability of drugs like rivaroxaban in obesity, the current evidence is limited by a lack of head-to-head comparative trials with enoxaparin. Therefore, they recommend DOACs as a viable alternative but call for future randomized controlled trials to establish definitive guidelines on the optimal prophylactic agent, dose, and duration. [7]

References: [1] Aminian A, Vosburg RW, Altieri MS, Hinojosa MW, Khorgami Z; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. The American Society for Metabolic and Bariatric Surgery (ASMBS) updated position statement on perioperative venous thromboembolism prophylaxis in bariatric surgery. Surg Obes Relat Dis. 2022;18(2):165-174. doi:10.1016/j.soard.2021.10.023
[2] Zhao Y, Ye Z, Lin J, et al. Efficacy and Safety of Pharmacoprophylaxis for Venous Thromboembolism in Patients Undergoing Bariatric Surgery: a Systematic Review and Meta-analysis. Obes Surg. 2022;32(5):1701-1718. doi:10.1007/s11695-021-05825-9
[3] Bartlett MA, Mauck KF, Stephenson CR, Ganesh R, Daniels PR. Perioperative Venous Thromboembolism Prophylaxis. Mayo Clin Proc. 2020;95(12):2775-2798. doi:10.1016/j.mayocp.2020.06.015
[4] Shelkrot M, Miraka J, Perez ME. Appropriate enoxaparin dose for venous thromboembolism prophylaxis in patients with extreme obesity. Hosp Pharm. 2014;49(8):740-747. doi:10.1310/hpj4908-740
[5] Ikesaka R, Delluc A, Gal GL, Carrier M. Efficacy and safety of weight-adjusted heparin prophylaxis for the prevention of acute venous thromboembolism among obese patients undergoing bariatric surgery: A systematic review and meta-analysis. Thrombosis Research. 2014;133(4):682-687. doi:10.1016/j.thromres.2014.01.021
[6] Jung YJ. Obesity and Venous Thromboembolism: Mechanisms, Clinical Implications, and Prevention Strategies With a Focus on Bariatric Surgery. J Metab Bariatr Surg. 2025;14(2):131-138. doi:10.17476/jmbs.2025.14.2.131
[7] Bicudo Bregion P, Rodrigues de Oliveira-Filho J, Ivano VK, Dallegrave Marchesini JC, Cazzo E. Efficacy and safety of direct oral anticoagulants (DOACs) for postoperative thromboprophylaxis in patients after bariatric surgery: a systematic review and meta-analysis. Surg Obes Relat Dis. 2025;21(9):1073-1083. doi:10.1016/j.soard.2025.05.004
Literature Review

A search of the published medical literature revealed 13 studies investigating the researchable question:

What are the current dosing recommendations for post-operative DVT prophylaxis in bariatric surgery patients? Are there any risk assessment or stratification tools available?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-13 for your response.


VTE Prophylaxis Recommendations, Stratified by Surgical Specialty and Estimated VTE Risk
Surgery Type Risk Strategy
Bariatric 

Moderate risk

Caprini < 4

Average bleeding risk: Mechanical prophylaxis with/without LMWH/LDUH (depending on patient’s VTE risk)
Most bariatric surgery High bleeding risk: Mechanical prophylaxis

High risk

Caprini ≥ 5

Additional VTE risk factors: age >55 years, BMI > 55 kg/m2, sleep apnea, pulmonary hypertension, revision surgery, postoperative anastomotic leak

Average bleeding risk: LMWH/ LDUH and mechanical prophylaxis

High bleeding risk: Mechanical prophylaxis

Considerations:

  • Prophylaxis is typically continued until the patient is ambulatory or until hospital dismissal
  • Consider extended duration (10-15 days) prophylaxis if very high risk
  • DOACs should not be used following bariatric surgery as absorption may be impaired
  • Consider weight-adjusting pharmacoprophylaxis in obese patients (see below)
Medication Dose Considerations
LDUH

Most operations: 5,000 IU SQ every 8 to 12 hours, starting 2 hours before surgery, most commonly administered every 8 hours

 

Preferred agent in the setting of renal impairment (CrCl < 30 mL/minute)  

Obesity: The optimal dose is unknown. Some experts use 7500 units twice daily

LMWH (Enoxaparin)

Abdominal surgery: 40 mg every 24 hours, starting 2 to 12 hours before surgery

Other: 40 mg every 24 hours, starting 10 to 12 hours before surgery

Renal impairment CrCl < 30 mL/minute: Avoid use. Some experts recommend enoxaparin 20 to 30 mg every 24 hours

Obesity (BMI > 40 kg/m2): 40 mg every 12 hours. We do not recommend adjusting dose based on anti-Xa levels as trials have not shown a clear link between anti-Xa levels and bleeding or thrombotic events. 

General considerations for heparin: 

  • All heparins carry a risk of HIT
  • Patients should undergo platelet count monitoring at day 5, 7, and 9
  • LMWH is the preferred pharmacoprophylactic agent following most operations
Abbreviations: BMI: body mass index; CrCl, creatinine clearance; HIT, heparin‐induced thrombocytopenia; LMWH, low-molecular-weight heparin; LDUH, low-dose unfractionated heparin; VTE, venous thromboembolism
 
References:
[1] Adapted from:
[2] Bartlett MA, Mauck KF, Stephenson CR, Ganesh R, Daniels PR. Perioperative Venous Thromboembolism Prophylaxis. Mayo Clin Proc. 2020;95(12):2775-2798. doi:10.1016/j.mayocp.2020.06.015
Comparison of key VTE prevention guidelines
Recommendations 2022 ASMBS guidelines 2024 European guidelines 2017 Asian guidelines
Recommended prophylaxis Pharmacological (LMWH, UFH, DOACs) and mechanical prophylaxis are recommended in combination. Pharmacological (LMWH, UFH, Fondaparinux) prophylaxis is recommended. LMWH is preferred over DOACs. Mechanical prophylaxis is not explicitly mentioned. Both pharmacological (LMWH is most common) and mechanical prophylaxis (e.g., IPC) are recommended. Mechanical prophylaxis is a priority if bleeding risk is high.
Pharmacological dosage Enoxaparin 40 mg twice daily, BMI/weight-tiered dosing, or based on anti-Xa levels. 2018: Low risk 3,000–4,000 IU, high risk 4,000–6,000 IU (every 12 hours). Dosage, frequency, and duration are determined by risk level. No specific figures are provided.
2024: Higher doses for patients with BMI >40kg/m2 or weight >150 kg.
Extended prophylaxis Recommended for select high-risk patients. Strongly recommended for high-risk patients for a minimum of 10 days. 2–4 weeks post-discharge for high-risk patients.
Specific high-risk factors BMI (≥50 kg/m2), age (≥60 years), prior history of VTE, thrombophilia, etc. BMI >40 kg/m2 or weight >150 kg, high-risk patients. BMI (≥50 kg/m2), older age (≥60 years), male gender, immobility, prior history of VTE, thrombophilia, OHS, etc.
Anti-Xa monitoring Consider dose adjustment based on anti-Xa levels. Explicitly does not recommend routine monitoring.  

 

References:
[1] Adapted from:
[2] Jung YJ. Obesity and Venous Thromboembolism: Mechanisms, Clinical Implications, and Prevention Strategies With a Focus on Bariatric Surgery. J Metab Bariatr Surg. 2025;14(2):131-138. doi:10.17476/jmbs.2025.14.2.131

 

Enoxaparin Thromboprophylaxis in Gastric Bypass Patients: Extended Duration, Dose Stratification, and Antifactor Xa Activity

Design

Prospective, open trial

N= 223

Objective

To evaluate the safety and efficacy of an extended duration, body mass index (BMI)–stratified enoxaparin thromboprophylaxis regimen in patients undergoing Roux-en-Y gastric bypass (RYGB) and to determine the resultant anti-factor Xa (AFXa) activity in morbidly obese surgical patients

Study Groups

Enoxaparin 40 mg (n=124)

Enoxaparin 60 mg (n= 99)

Methods

Inclusion criteria: patients ≥18 years old, met the eligibility criteria for bariatric surgery established by the National Institutes of Health and underwent first-time RYGB.

Exclusion criteria: serum creatinine 1.6 mg/dL, a history of VTE or known hypercoagulable state, chronic warfarin use, and a contraindication or hypersensitivity to unfractionated heparin (UFH)  or low molecular weight heparin (LMWH), including a history of heparin-induced thrombocytopenia

Pharmacologic prophylaxis began with a fixed dose of subcutaneous UFH 5000 IU given within 2 hours before surgery. Enoxaparin was started 12 hours after surgery, administered subcutaneously every 12 hours during hospitalization, and continued once daily for 10 days after discharge. Patients with a BMI of 50 kg/mreceived 40 mg, and patients with a BMI of 50 kg/m2 received 60 mg. 

AFXa activity was measured in all patients 4 hours after the third enoxaparin dose.

Duration

Follow-up: 3 months

Outcome Measures

Safety and efficacy endpoint: major bleeding and clinically evident VTE occurring≤3 months after surgery

Baseline Characteristics

 

Enoxaparin 40 mg (n=124)

Enoxaparin 60 mg (n= 99)

All patients (N= 223)

Age, years

44.7 ± 10.1 44.3 ± 10.6 44.5 ± 10.3

Women

96 (77.4%) 72 (72.7%)

168 (75.0%)

BMI, kg/m2

44.9 ± 3.7 57.4 ± 6.4 50.4 ± 8

Length of hospital stay, days

3.4 ± 1.5 3.6 ± 1.9 3.5 ± 1.6

Results

 

Enoxaparin 40 mg (n=109)

Enoxaparin 60 mg (n= 97)

All patients (N= 206)

Major bleeding events

4 (3.2%) 1 (1.0%) 5 (2.2%)

AFXa Concentration, IU/mL

<0.18

0.18- 0.44

>0.44

0.26 ± 0.10

23 (21.1%)

86 (78.9%)

0 (0.0%)

0.32 ± 0.13 

14 (14.4%)

67 (69.1%)

16 (16.5%)

 

37 (18%)

153 (74.3%)

16 (7.8%) 

Acheived AFXa levels after 3 doses

86 (79%)

67 (69%)

 

The AFXa activity levels at 0.5, 4, and 11 hours after the first enoxaparin dose did not consistently reach the prophylactic range in either dose group.

Of the 223 patients, 17 (7.6%) developed clinical manifestations suggestive of VTE and underwent diagnostic testing procedures. Deep vein thrombosis and pulmonary embolism were diagnosed in 1 patient (0.45%) on postoperative day 37.

Adverse Events

Significant bleeding or anemia occurred in 5 patients [4 (3.2%) vs. 1 (1.0%)]

Study Author Conclusions

Extended duration, BMI-stratified regimen using higher than standard doses of enoxaparin provided effective prophylaxis and was well tolerated without increasing the risk for bleeding in patients undergoing open or laparoscopic RYGB. The steady-state AFXa levels were within the target prophylactic range in most patients, and none reached a full anticoagulation concentration.

InpharmD Researcher Critique

The results of the study cannot be generalized to patients with a history of VTE since the study excluded this patient population. The study did not clinically detect silent VTE.



References:
[1] Borkgren-Okonek MJ, Hart RW, Pantano JE, et al. Enoxaparin thromboprophylaxis in gastric bypass patients: extended duration, dose stratification, and antifactor Xa activity. Surg Obes Relat Dis. 2008;4(5):625-631. doi:10.1016/j.soard.2007.11.010

 

Routine Anticoagulation for Venous Thromboembolism Prevention Following Laparoscopic Gastric Bypass

Design

Retrospective, single-center, pre-post study

N= 1,692

Objective

To compare the rates of venous thromboembolism (VTE) by using routine postoperative enoxaparin versus early ambulation, sequential compression devices (SCDs), hydration, and selective prophylactic pharmacologic anticoagulation

Study Groups

Enoxaparin: received routine postoperative enoxaparin 40 mg subcutaneously BID + with sequential compression devices (n= 435)

No Routine Anticoagulation: only received sequential compression devices (n= 1,257)

Methods

Inclusion criteria: patients who underwent laparoscopic Roux-en-Y gastric bypass (RYGB) by a single surgeon

Exclusion criteria: patients deemed to be high-risk and received inferior vena cava (IVC) filters

This was a retrospective study of consecutive patients who underwent bariatric surgery at an institution in Chicago. Patients were divided into two groups based on whether their surgery was performed before or after a change in postoperative care protocol occurred in January 2003. If patients were operated on between October 2001 and January 2003, then they received routine postoperative enoxaparin 40 mg subcutaneously BID with calf-length sequential compression devices (SCDs).

If patients were operated on after January 2003, then they had SCDs placed, but did not receive routine anticoagulation (unless they had a personal or family history of a hypercoagulable state or VTE). All patients were seen in follow-up at 1 week, 1 month, 3 months, 6 months, 1 year, and annually thereafter. 

Duration

Enoxaparin: October 2001 to January 2003

No anticoagulation: February 2003 to October 2008

Outcome Measures

Length of hospital stay, intraluminal bleeding, pulmonary embolism, DVT, non-VTE related deaths

Baseline Characteristics

 

Enoxaparin (n= 435)

No Routine Anticoagulation (n= 1,257)

Age, years (range)

42.7 (14-72) 42.7 (14-72)

Female

365 (84%) 1056 (84%) 

BMI, kg/m2 (range)

51.6 ± 4 (39-91) 45.3 ± 3 (35-67) 

Results

 

Enoxaparin (n= 435)

No Routine Anticoagulation (n= 1,257)

Operating Time, minutes

144 ± 26

126 ± 15

Length of Hospital Stay, days

2.3 ± 1.5

1.4 ± 1.2

Deep Vein Thrombosis

7 (1.6%) 6 (0.48%)

Pulmonary Embolism

5 (1.1%) 0 (0%)

Intraluminal Bleeding

21 (4.8%) 5 (0.4%)

Mortality

2 (0.46%) 0 (0%)

Adverse Events

Common Adverse Events: N/A

Study Author Conclusions

Adequate VTE prophylaxis is achieved using SCDs, early ambulation, emphasis on hydration, and shorter operating times. Bariatric surgery can be safely performed without pharmacologic VTE prophylaxis in all but the high-risk population. Fewer bleeding complications occur without the use of anticoagulants.

InpharmD Researcher Critique

This study had a limitation in that the group with no routine anticoagulation may have had more favorable results due to having a lower average BMI compared to the enoxaparin group (51.6 vs 45.3). Additionally, this was a consecutive study where later surgeries could have been conducted when the single surgeon had more experience and/or was more comfortable.

 

 

References:
[1] Frantzides CT, Welle SN, Ruff TM, Frantzides AT. Routine Anticoagulation for Venous Thromboembolism Prevention Following Laparoscopic Gastric Bypass. JSLS : Journal of the Society of Laparoendoscopic Surgeons. 2012;16(1):33-37. doi:10.4293/108680812x13291597716906

 

Enoxaparin for Thromboprophylaxis in Morbidly Obese Patients Undergoing Bariatric Surgery: Findings of the Prophylaxis Against VTE Outcomes in Bariatric Surgery Patients Receiving Enoxaparin (PROBE) Study

Design

Multicenter, retrospective survey study

N=668

Objective

to evaluate the safety and efficacy of enoxaparin for thromboprophylaxis in patients with morbid obesity undergoing primary bariatric surger

Study Groups

Center A: The California Institute for Minimally Invasive Surgery, California (n= 100)

Center B: West Coast Surgical Specialists, Florida (n= 124)

Center C: Hurley Medical Center, Michigan (n= 84)

Center D: Bariatric Care Centers of Ohio, Ohio (n= 180)

Center E: Magee-Womens Hospital of the University of Pittsburgh Medical Center, Pennsylvania (n=180)

Methods

Primary bariatric surgeries completed at five different centers (listed above) from January to December 2002 were analyzed retrospectively. The varying enoxaparin dosing for each center is listed below.

Enoxaparin Dosing and duration

Center A (n= 100): 30 mg preoperatively: NA

Center B (n= 124): 30 mg post-discharge q24h: 10 days

Center C (n= 84): 40 mg q24h postoperatively: 12-120 hours

Center D (n= 180): 40 mg q24h postoperatively: 12-24 hours

Center E (n= 180): 40 mg q12h postoperatively: 12-36 hours

Duration

January 2002 - December 2002 at all centers

Outcome Measures

Postoperative PE and/or DVT

Baseline Characteristics

 

Center A

(n= 100)

Center B

(n= 124)

Center C

(n= 84)

Center D

(n= 180)

Center E

(n= 180)

All centers

(N= 668)

Age, years

39.5 ± 9.1  42.1 ± 10.7  47.5 ± 9.0  41.9 ± 9.5  39.7 ± 9.1  41.7 ± 9.9 

Women

75%  82% 71% 90% 97% 86%

BMI, kg/m2

47.0 ± 7.4  51.5 ± 7.7  56.8 ± 10.1  49.9 ± 8.7   46.0 ± 5.1   49.6 ± 8.4

History of VTE

0 (0%)   2 (1.6%) 6 (7.1%)  0 (0%)  3 (1.6%)  11 (1.6%)

Length of stay, days

2.3 ± 0.9 4.3 ± 3.3 4.8 ± 5.3 2.9 ± 0.6 2.5 ± 1.5 3.2 ± 2.7

Results

 

VTE diagnosis

Length of stay, days

Time from surgery to diagnosis

Enoxaparin dose Duration of Enoxaparin  

Center A

PE

PE

NR

2

18 days

7 days

30 mg preoperative

30 mg preoperative

N/A

N/A

 

Center B

DVT

PE

PE

3

2

10

Unknown

10 days

11 days

30 mg Q24 h

Not reported

30 mg Q24 h

10 days

Not reported

10 days

 

Center C

PE

34 14 days 40 mg Q24 h 10 days  

Center E

PE 2 16 days 40 mg Q24 h 2 days  

A total of 7 patients (1%) were diagnosed with postoperative VTE with a mean follow-up of 10.5±7.1 months. All incidences of VTE are listed above.

All deaths in the study occurred at Center B (all due to bleeding complications). In addition, 6 (0.9%) other severe bleeding complications were observed at Centers D and E. 

Adverse Events

N/A

Study Author Conclusions

The administration of enoxaparin, in various dosing regimens, is safe for thromboprophylaxis in morbidly obese patients undergoing bariatric surgery. All thromboembolic events occurred after the cessation of thromboprophylaxis, so extended thromboprophylaxis may be of value.

InpharmD Researcher Critique

A limitation of this study is that there was no control group to compare the data. Given that this was a retrospective study, there is also a potential for selection and recall bias. 



References:
[1] Hamad GG, Choban PS. Enoxaparin for thromboprophylaxis in morbidly obese patients undergoing bariatric surgery: findings of the prophylaxis against VTE outcomes in bariatric surgery patients receiving enoxaparin (PROBE) study. Obes Surg. 2005;15(10):1368-1374. doi:10.1381/096089205774859245

 

Comparison of Two Low-molecular-weight Heparin Dosing Regimens for Patients Undergoing Laparoscopic Bariatric Surgery

Design

Prospective, non-randomized, open-label, single-center, observational study

N= 40

Objective

To compare and assess the anti-Xa concentrations between 60mg and 40mg enoxaparin in laparoscopic bariatric surgery

Study Groups

40 mg (n= 24)

60 mg (n= 16)

Methods

Inclusion criteria: underwent laparoscopic gastric bypass or laparoscopic adjustable gastric band (LAGB) placement at a single center in Tennesee by one of two surgeons

Exclusion criteria: levels not drawn correctly, enoxaparin held for bleeding concerns

Patients admitted for bariatric surgery received enoxaparin (either 40mg or 60 mg) q12h, starting with the first dose at 11 PM the day of the surgery. The anti-Xa levels were drawn 4 hours after the first and third dose; the therapeutic range was 0.18 - 0.44 U/mL. For patients undergoing LAGB, only first dose concentrations were obtained since these patients were typically discharged prior to the third dose.

The doses were selected by the two surgeons. Surgeon A mainly used enoxaparin 60 mg q12h, except in patients with a higher risk of bleeding (who received 40 mg q12h). Surgeon B only used enoxaparin 40 mg q12h and also give a preoperative dose 30 mins before surgery.

Duration

November 2006 to March 2007

Outcome Measures

Anti-Xa levels (U/mL)

Baseline Characteristics

 

40 mg (n= 24)

60 mg (n= 16)

P-value

Age, years

40.0 ± 9.8  41.0 ± 10.2 NS

Female

87.5%  93.7% NS

BMI, kg/m2

48.8 ± 6.6  47.3 ± 6.6 NS

Surgeon A

8% 100% <0.0001

Preoperative Lovenox 

92% 0%  <0.0001

Gastric bypass

45.8% 50% NS

Results

 

40 mg (n= 24)

60 mg (n= 16)

P-value

Anti-Xa level after 1st dose, U/mL

Anti-Xa level after 3rd dose, U/mL

0.173

0.212

0.261

0.433

<0.005

<0.001

Subtherapeutic anti-Xa level after 1st dose

Subtherapeutic anti-Xa level after 3rd dose

55%

44%

20%

0%

NS

0.02

Supratherapeutic anti-Xa level after 1st dose

Supratherapeutic anti-Xa level after 3rd dose

0%

0%

6%

57%

NS

0.02

Adverse Events

Serious Adverse Events: One patient experienced significant bleeding in the 40mg dose group. The patient required a blood transfusion and vitamin K.

The study excluded 10 patients. The levels were not drawn correctly for 3 patients and 7 patients had enoxaparin held for bleeding concerns (4 in the 40 mg group and 3 in the 60 mg group). 

Study Author Conclusions

Enoxaparin 60-mg q12h was superior to a dosage of 40 mg q12h in achieving therapeutic anti-Xa concentrations and avoiding subtherapeutic anti-Xa levels.

InpharmD Researcher Critique

This study had a relatively small sample size; the dose being selected by the surgeon could also introduce bias to the study. While this was a prospective, observational study, it was not randomized or blinded. This study was designed to evaluate surrogate endpoints (anti-Xa levels) instead of clinical endpoints (e.g., bleeding, VTE incidence). 



References:
[1] Simone EP, Madan AK, Tichansky DS, Kuhl DA, Lee MD. Comparison of two low-molecular-weight heparin dosing regimens for patients undergoing laparoscopic bariatric surgery. Surg Endosc. 2008;22(11):2392-5.

 

Anti-Xa Levels in Bariatric Surgery Patients Receiving Prophylactic Enoxaparin

Design

Non-randomized, consecutive, open-label study

N= 52

Objective

To characterize anti-Xa levels in bariatric surgery patients receiving prophylactic enoxaparin

Study Groups

Enoxaparin 30 mg (n= 19)

Enoxaparin 40 mg (n= 33)

Methods

Inclusion criteria: any patient undergoing laparoscopic banding or laparoscopic gastric bypass surgery at a single center

Exclusion criteria: patients with anti-Xa levels drawn earlier than 3 h postdose or later than 5 h postdose

Patients who underwent laparoscopic gastric bypass or banding were enrolled and divided into two groups (enoxaparin 30 mg or enoxaparin 40 mg) depending on their surgery date. All patients received their first dose at 11 PM on the day of surgery and then every 12 hours. One of the two surgeons gave an enoxaparin dose before anesthesia induction, while the other did not.

Anti-Xa levels were obtained 4 hours after the first and third doses, with levels between 0.18 - 0.44 units/mL considered appropriate. 

Duration

Enoxaparin 30 mg: October 2005 to December 2005

Enoxaparin 40 mg: December 2005 to April 2006

Outcome Measures

Therapeutic anti-Xa levels after 1st and 3rd doses of enoxaparin

Baseline Characteristics

 

Enoxaparin 30 mg (n= 19)

Enoxaparin 40 mg (n= 33)

Age, years

41.7 ± 10.7 40.8 ± 9.1 

Women

14 (74%) 27 (82%) 

Weight, kg

141.6 ± 25.4 135.6 ± 27.9 

BMI, kg/m2

48.4 ± 7.1 48.5 ± 8.5

Results

 

Enoxaparin 30 mg (n= 19)

Enoxaparin 40 mg (n= 33)

Anti-Xa levels after 1st dose

0.06 units/mL 0.14 units/mL 

Anti-Xa levels after 3rd dose

0.08 units/mL

0.15 units/mL

Therapeutic after 1st dose

0.0% 30.8%

Therapeutic after 3rd dose

9.1% 41.7%

A significant difference was seen between the 30 and 40 mg regimens in terms of anti-Xa levels (P<0.05) and patients who were therapeutic (P=0.01).

Adverse Events

Not reported

Study Author Conclusions

When prophylactic dose enoxaparin of 30 mg every 12 h was changed to 40 mg every 12 h in bariatric surgery patients, anti-Xa levels significantly increased with prophylactic dose enoxaparin in bariatric surgery patients. The percentage of appropriate levels also increased; however, more than half of the patients receiving 40 mg every 12 hours failed to reach therapeutic levels. No levels were supratherapeutic. Dosage of 40 mg every 12 h may not be sufficient for bariatric surgery patients.

InpharmD Researcher Critique

There were several limitations in this study, including (1) an unknown correspondence between these anti-Xa levels and bleeding rates or occurrence of thromboembolism, (2) not measuring risk factors or outcomes of bleeding and thromboembolism during hospitalization or follow-up clinic visits, (3) a relatively small sample size that could bias the results, (4) different time periods, (5) differences in dosing regimen between the two surgeons, and (6) not being a randomized study that looked at clinical outcomes. 



References:
[1] Rowan BO, Kuhl DA, Lee MD, Tichansky DS, Madan AK. Anti-Xa levels in bariatric surgery patients receiving prophylactic enoxaparin. Obes Surg. 2008;18(2):162-6.

 

Fixed-Dose Enoxaparin After Bariatric Surgery: The Influence of Body Weight on Peak Anti-Xa Levels

Design

Prospective, observational study

N= 51

Objective

To investigate the correlation between anti-factor Xa (anti-Xa) levels and body weight with fixed-dose enoxaparin after bariatric surgery and to investigate the percentage of patients that reach the desired prophylactic range for anti-Xa levels

Study Groups

<110kg; (n= 17)

110-150 kg; (n= 18)

>150kg (n= 16)

Methods

Inclusion criteria: patients who had an outpatient check-up 8-16 days after bariatric surgery, still using enoxaparin according to the local thromboprophylaxis protocol post-operation

Exclusion criteria: enoxaparin dosage different from that specified in the protocol, antithrombin III deficiency, renal insufficiency

Patients were prescribed fixed-dose subcutaneous enoxaparin 40 mg q12h for 14 days, with the first dose administered in the evening on the day of surgery. Blood for anti-Xa peak levels measurement was drawn 3–5 h after administration of enoxaparin, at the planned visit to the outpatient clinic 8–16 days after surgery.

Duration

Enoxaparin use: 14 days

Outcome Measures

Percentage of patients within the prophylactic range in different weight categories and the relation between body weight and anti-Xa levels

Baseline Characteristics

 

<110 kg (n= 17)

110-150 kg (n= 18) >150 kg (n= 16) P-value
Age, years

49.2 ± 8.4

41.6 ± 10.4

40.8 ± 9.4

0.022

Female

14 (82.4%)

16 (88.9%)

8 (50%)

0.023

Weight, kg

100.2 ± 7.6

123.6 ± 7.7 

160.9 ± 7.4

<0.001

Lean body weight, kg

54.6 ± 8.2 

62.7 ± 6.8

79.7 ± 12.3

<0.001

BMI, kg/m2

36.8 ± 4.3

40.8 ± 3.6 

49.3 ± 6.8

<0.001

Results

 

<110 kg (n= 17)

110-150 kg (n= 18)

>150 kg (n= 16)

P-value

Anti-Xa level

0.47 ± 0.13

0.39 ± 0.08

0.23 ± 0.07

<0.001 

Subtherapeutic <0.2 IU/mL

0

0

6 (37.5%)

0.001

Therapeutic 0.2–0.5 IU/mL

11 (64.7%)

17 (94.4%)

10 (62.5%)

0.054

Supratherapeutic >0.5 IU/mL

6 (35.3%)

1 (5.6%) 

0

0.006

Adverse Events

No thromboembolic events were reported; no major bleeding complications

Eight patients (16%) had minor bleeding; five patients (29.4%) <110 kg, two patients (11.1%) 110-150 kg, one patient (6.3%) >150 kg. All patients with minor bleeding complications had anti-Xa levels within the advised prophylactic range of 0.2–0.5 IU/mL.

Study Author Conclusions

Patients with excessive body weight may not be adequately treated with fixed-dose enoxaparin 40 mg q12h thromboprophylaxis while patients with lower body weight may have an increased bleeding risk. Actual body weight is a better predictor of anti-Xa levels compared to lean body weight.

InpharmD Researcher Critique

The sample size was too small to adequately power this study for clinical outcomes (e.g., VTE, bleeding). The weight classes chosen to divide up these patients was arbitrary, but the middle group represented the general bariatric population.



References:
[1] Celik F, Huitema AD, Hooijberg JH, van de Laar AW, Brandjes DP, Gerdes VE. Fixed-dose enoxaparin after bariatric surgery: the influence of body weight on peak anti-Xa levels. Obes Surg. 2015;25(4):628-634. doi:10.1007/s11695-014-1435-3
Effectiveness of Body Mass Index-Based Prophylactic Enoxaparin Dosing in Bariatric Surgery Patients
Design

Retrospective study

N= 137

Objective To evaluate the effectiveness of BMI-based prophylactic enoxaparin dosing at achieving target peak anti-Xa levels
Study Groups All patients (N= 137)
Inclusion Criteria Patients who underwent bariatric surgery at an academic medical center and had an anti-Xa level drawn 2.5-6 h after ≥3 doses of BMI-based prophylactic enoxaparin
Exclusion Criteria Patients who received enoxaparin doses different from the program guidelines or had an incorrectly timed anti-Xa blood draw
Methods Patients received BMI-based VTE prophylactic enoxaparin. Anti-Xa levels were drawn 2.5-6 hours after ≥3 doses. BMI-based dosing: BMI 30-40 kg/m2 received 40 mg daily, BMI 40-50 kg/m2 received 40 mg BID, BMI >50 kg/m2 received 60 mg BID. Anti-Xa levels checked before discharge for high-risk patients
Duration January 2015 to May 2021
Outcome Measures Primary: Percentage of patients achieving target anti-Xa level (0.2-0.5 IU/mL) Secondary: Prevalence of VTE and bleeding events within 30 days post-operatively, correlation between anti-Xa levels and enoxaparin dose per EBV vs. dose per BMI
Baseline Characteristics Characteristic All patients (N= 137)
Age 43.87 (13.34)
Female 110 (80.3%)

Surgery type 

Bypass

Sleeve

 

40 (29.2%)

96 (70.1%)

Race

Non-Hispanic White

African American

 

78 (56.9%)

52 (38.0%)

Pre-operative height, cm 166.64 (8.95)
Pre-operative weight, kg 164.90 (33.80)
BMI, kg/m2 59.06 (10.39)
EBV, L 7.36 (1.34)
Results Anti-Xa level Below target Within target Above target
Number of patients 7 (5.1%) 116 (84.7%) 14 (10.2%)
Patients with above target anti-Xa levels were significantly shorter in height than those within target range (167.1 ves. 159.8 cm, p= 0.003), , suggesting an increased risk of overdosing enoxaparin in shorter, obese patients
Adverse Events Five patients (3.6%) had a bleeding event; no thromboembolisms occurred.
Study Author Conclusions Target range anti-Xa levels were achieved in 85% of patients using BMI-based enoxaparin dosing. An EBV-based dosing regimen may better account for patient height and is supported by a greater correlation with anti-Xa levels with dosing based on EBV than BMI
Critique The study highlights the potential inadequacy of BMI-based dosing in shorter patients, suggesting EBV-based dosing as a more accurate alternative. However, the retrospective design and limited sample size may affect the generalizability of the findings. Further prospective studies are needed to validate the EBV-based dosing approach
 
References:
[1] Chang CK, Higgins RM, Rein L, Peppard WJ, Herrmann DJ, Kindel T. Effectiveness of Body Mass Index-Based Prophylactic Enoxaparin Dosing in Bariatric Surgery Patients. J Surg Res. 2023;287:168-175. doi:10.1016/j.jss.2023.01.018
Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery
Design

Assessor-blinded, phase 2, multicenter randomized clinical trial

N= 272

Objective To assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery
Study Groups

7-day prophylaxis (n= 134)

28-day prophylaxis (n= 135)

Inclusion Criteria Body mass index (BMI) >35, age ≥18 years, failure of conservative treatment for 2 years
Exclusion Criteria Pregnant or breastfeeding, active bleeding or high risk of bleeding, history of VTE
Methods Patients were randomized 1 day after bariatric surgery to receive 10 mg of oral rivaroxaban for either 7 days or 28 days. Bilateral compression ultrasonography screening of both legs was performed after 28 days, and a safety follow-up visit was conducted at day 35
Duration July 1, 2018, through June 30, 2021
Outcome Measures

Primary: Composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days

Secondary: Major bleeding, clinically relevant nonmajor bleeding, mortality

Baseline Characteristics   Rivaroxaban 7 d (n= 134) Rivaroxaban 28 d (n= 135)
Age, mean (SD), y 39.9 (12.1) 40.1 (12.2)
Female 108 (80.6%) 108 (80.0%)
BMI, mean (SD) 41.7 (5.1) 42.6 (6.5)
Results   Rivaroxaban 7 d (n= 129) Rivaroxaban 28 d (n= 128)
Asymptomatic VTE 0 (0.0%) 1 (0.8%)
Major or clinically relevant nonmajor bleeding 2 (1.5%) 3 (2.2%)
Adverse Events Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm
Study Author Conclusions Once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups
Critique The lack of a low-molecular-weight heparin (LMWH) treatment arm limits direct comparison. The small number of primary outcome events and the relatively small sample size compared to larger phase 3 trials are limitations. The inclusion of compression ultrasonography to detect asymptomatic DVT increases the validity of the efficacy results.

 

References:
[1] Kröll D, Nett PC, Rommers N, et al. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(5):e2315241. Published 2023 May 1. doi:10.1001/jamanetworkopen.2023.15241

Adding a Preoperative Dose of LMWH may Decrease VTE Following Bariatric Surgery

Design

Single-center, prospective randomized study

N= 100

Objective

To assess the optimum low-molecular-weight heparin (LMWH) regimen for venous thromboembolism (VTE) prophylaxis in bariatric procedures and to reduce the incidence of perioperative bleeding

Study Groups

Postoperative LMWH (n= 50)

Pre- and postoperative LMWH (n= 50)

Inclusion Criteria

Eligible for sleeve gastrectomy, body-mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with comorbidities

Exclusion Criteria

Risk factors for VTE other than obesity (e.g., previous history of VTE, taking oral contraceptive pills, known thrombophilic patients)

Methods

Patients were randomized to receive only postoperative LMWH or both pre- and postoperative LMWH. Patients only receiving postoperative LMWH were given enoxaparin alone starting from day 1 to day 15 at a dose of 1 mg/kg/day up to a maximum dose of 120 mg/day. Patients receiving both pre- and postoperative LMWH were given LMWH 12 hours preoperatively and postoperatively starting from day 1 to day 15 at a dose of 1 mg/kg/day to a maximum dose of 120 mg/day. All patients underwent laparoscopic sleeve gastrectomy under general anesthesia, as well as mesenteric, portal bilateral lower limb duplex 15 days postoperatively to evaluate for VTE.

Duration

Surgery: July 2018 to January 2019

Outcome Measures

Postoperative silent VTE or bleeding

Follow-up: 15 days postoperatively

Baseline Characteristics

 

Postoperative LMWH (n= 50)

Pre- and postoperative LMWH (n= 50)

 

Age, years

34.04 ± 9.381  33.78 ± 9.721  

Female

88% 80%  

BMI, kg/m2

47.963 ± 5.517 48.778 ± 5.617  

Caprini score

3.08 ± 0.34 3 ± 0.31  

Operative time, hours

1.75 ± 0.5825 1.7 ± 0.544  

No statistically significant differences between groups for baseline characteristics. 

Results

Endpoint

Postoperative LMWH (n= 50)

Pre- and postoperative LMWH (n= 50)

p-value

Postoperative silent VTE 

4 (8%) 0 0.041

Postoperative bleeding

0 1 (2%) 0.315

Adverse Events

N/A

Study Author Conclusions

Preoperative as well as a postoperative prophylactic anticoagulant as LMWH is recommended to prevent perioperative VTE. There was an insignificant increase in postoperative bleeding in patients who received preoperative prophylactic anticoagulants.

InpharmD Researcher Critique

Patients received individualized hydration, which may have affected the rate of VTE. The small sample size also could have confounded the results.

 

 
References:
[1] Abdelsalam AM, ElAnsary AMSE, Salman MA, Nassef SA, Elfergany HM, Aisha HAA. Adding a Preoperative Dose of LMWH may Decrease VTE Following Bariatric Surgery. World J Surg. 2021;45(1):126-131. doi:10.1007/s00268-020-05782-x
Application of the Caprini Risk Assessment Model to Select Patients for Extended Thromboembolism Prophylaxis After Sleeve Gastrectomy
Design

Retrospective chart review

N= 638

Objective To examine whether the Caprini risk assessment model can be safely applied to LSG patients to minimize the incidence of postoperative VTE, including PMVT, without increasing the likelihood of bleeding complications
Study Groups

Caprini score <5 (n= 480)

Caprini score ≥5 (n= 158)

Inclusion Criteria Patients who underwent LSG at the institution from 2010 to 2018
Exclusion Criteria None specified
Methods

Patients received preoperative UFH based on BMI, with SCDs during operation. Postoperative UFH was administered every 8 hours. Extended VTE prophylaxis with LMWH was given based on Caprini scores: 0-4 (none), 5-8 (7-10 days), ≥9 (30 days). LMWH dosage was adjusted based on BMI.

Duration March 2010 to May 2018
Outcome Measures

Primary: Incidence of postoperative VTE, including PMVT

Secondary: Incidence of bleeding complications

Baseline Characteristics   Caprini score <5 (n= 480) Caprini score ≥5 (n= 158) p-value
Age, years (mean ± SD) 38.8 ± 9.9 48.9 ± 12.9 p < 0.0001
Female (%) 83.3 76.6 ns
Preoperative BMI (mean ± SD) 44.0 ± 6.2 45.7 ± 8.1 p = 0.008
Postoperative BMI (mean ± SD) 35.2 ± 6.9 35.9 ± 8.4 ns
Caprini score (mean ± SD) 3.5 ± 0.5 6.0 ± 1.3 p < 0.0001
Hypertension (%) 38.8 58.2 p < 0.0001
GERD (%) 26.7 36.1 p = 0.026
OSA (%) 22.7 38.6 p < 0.001
Diabetes (%) 19.6 36.1 p < 0.0001
Hyperlipidemia (%) 10.2 26.6 p < 0.0001
Osteoarthritis (%) 6.9 18.4 p < 0.0001
Cancer (%) 0.8 8.2 p < 0.0001
Pseudotumor cerebri (%) 0.6 3.2 p = 0.025
Myocardial infarction (%) 0.4 2.5 p = 0.036
Lung disease (%) 0.4 8.2 p < 0.0001
Stroke (%) 0.2 1.9 p = 0.049
Personal history of DVT/PE (%) 0.0 13.9 p < 0.0001
Family history of DVT/PE (%) 0.0 26.6 p < 0.0001
Results   Caprini score <5 (n= 480) Caprini score ≥5 (n= 158) p-value
VTE events 0 3 (1.9%) <0.001
Bleeding complications 0 0 ns
Adverse Events No bleeding complications were observed among patients who received extended VTE prophylaxis
Study Author Conclusions The Caprini risk assessment model can effectively identify patients after LSG who might benefit from extended courses of VTE prophylaxis. Extended VTE prophylaxis does not seem to confer increased bleeding risk in this patient population.
Critique

The study effectively demonstrates the utility of the Caprini RAM in identifying high-risk patients for extended VTE prophylaxis after LSG, with a low incidence of VTE and no bleeding complications. However, the retrospective design and single-institution setting may limit generalizability. Additionally, the study did not include a control group or assess patient compliance with prophylaxis, which could impact the findings.

 

References:
[1] Hasley RB, Aly S, Carter CO, et al. Application of the Caprini Risk Assessment Model to Select Patients for Extended Thromboembolism Prophylaxis After Sleeve Gastrectomy. J Gastrointest Surg. 2022;26(2):298-304. doi:10.1007/s11605-021-05214-8
Extended postoperative venous thromboembolism prophylaxis after bariatric surgery: a comparison of existing risk-stratification tools and 5-year MBSAQIP analysis
Design

Retrospective analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database

N= 709,304

Objective To review existing risk-stratification tools and compare their predictive abilities
Study Groups All patients (n= 709,304)
Inclusion Criteria Patients with a BMI ≥35 kg/m2 who underwent LRYGB or LSG between 2015 and 2019
Exclusion Criteria Patients younger than 18 years, with previous obesity/foregut surgery, therapeutic anticoagulation, or inferior vena cava filter in place; emergency operations and operations not on the day of admission
Methods

Retrospective analysis of MBSAQIP database for primary minimally invasive MBS cases. Evaluated VTE clinical factors and risk-assessment tools: BMI threshold of 50 kg/m2, Caprini RAM, Cleveland Clinic VTE risk tool, Michigan Bariatric Surgery Collaborative tool, and BariClot. Assessed sensitivity, specificity, and positive predictive value for high-risk patients.

Duration 2015 to 2019
Outcome Measures

Primary: Predictive performance of VTE risk-assessment tools

Secondary: Sensitivity, specificity, and positive predictive value of each tool

Baseline Characteristics   All patients (n= 709,304)
Age, years 44.02 ± 11.8
Male 140,478 (19.8%)
BMI, kg/m2 43.94 ± 7.56
OSA 265,762 (37.5%)
GERD 212,007 (29.9%)
Hypertension 329,598 (46.5%)
Diabetes 178,869 (25.2%)
COPD 10,238 (1.44%)
History of VTE 9642 (1.36%)
Smoker past year 60,018 (8.46%)
Results   Sensitivity Specificity PPV NPV ROC area
BMI >50 kg/m2 0.26 0.77 0.004 0.996 0.521
Caprini RAM 0.17 0.89 0.006 0.996 0.541
Cleveland Clinic 0.32 0.84 0.008 0.997 0.596
Michigan Bariatric Surgery Collaborative 0.046 0.99 0.02 0.996 0.562
BariClot 0.078 0.98 0.016 0.997 0.593
Adverse Events Not applicable
Study Author Conclusions

Existing MBS VTE risk-assessment tools differ widely for inclusion variables, high-risk definition, and predictive performance. Further research and registry inclusion of all significant risk factors are needed to determine the optimal risk-stratified approach for predicting VTE events and determining the need for extended prophylaxis.

Critique

The study provides a comprehensive comparison of existing VTE risk-assessment tools, highlighting their variability in predictive performance. However, the retrospective design and reliance on MBSAQIP data may limit the generalizability of the findings. Missing variables in the data set could have impacted the accuracy of some risk scores, and the study does not account for postdischarge VTE events beyond 30 days. Additionally, the study does not address the potential bleeding risks associated with extended prophylaxis.

 

References:
[1] Imbus JR, Jung AD, Davis S Jr, et al. Extended postoperative venous thromboembolism prophylaxis after bariatric surgery: a comparison of existing risk-stratification tools and 5-year MBSAQIP analysis. Surg Obes Relat Dis. 2023;19(8):808-816. doi:10.1016/j.soard.2023.04.329