Evidence Table 32. Study characteristics kq6



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Evidence Table 32. Study characteristics KQ6

Author, Year

Study Design

Study Site – Study Locations

Recruitment Date (start date – end date)

Planned Length of Follow-up

Method of Surveillance for VTE

Funding Source

Inclusion Criteria

Exclusion Criteria

IVCF versus IVCF

Van Ha, TG, 20111

Retrospective Cohort

Single center- North America

2005-2008

10 weeks (4 weeks post placement + 6 weeks post retrieval)

All patients underwent venous color-flow duplex ultrasound of the lower extremities 1 week before filter removal to rule out lower extremity DVT.

 NR

BMI- >50 kg/m2

One patient undergoing removal of a retroperitoneal primitive neuroectodermal tumor received bilateral iliac filter placement not because of megacava, but to prevent potential surgical field disruption caused by IVC placement.

All patients underwent full assessment and informed consent for retrievable filter placement and subsequent retrieval.


NR

IVCF versus Control

Birkmeyer, N. J.2

Retrospective Cohort

Multi- center- North America

2006-2008

NR

NR

Longitudinal

Open or laparoscopic gastric bypass procedure

Revisional surgery, laparoscopic gastric banding, biliopancreatic diversion, sleeve gastrectomy procedures

IVCF versus Control

Gargiulo, N.J., 20063

Ambidirectional- Retrospective-Prospective Cohort

Single center- North America

1999-2005

NR

DVT: All patients had routine pre and post-operative lower extremity venous duplex examination.

PE: For patients with clinical sequelae suggestive of a PE, PEs were documented by spiral CT, V/Q scan or autopsy within the perioperative period (30 days after surgery)



NR

NR

NR

Li, W., 20124

Retrospective Cohort

Multi- center- North America

2007-2009

90 day post operative follow-up visit information was collected

NR

Surgical Review Corporation

Patients undergoing Roux-en-Y gastric bypass and adjustable gastric banding surgeries.

NR

Obeid, F. N., 20075

Retrospective Cohort

Single center- North America

2000-2006

NR

NR

NR

NR

NR

Overby, D. W., 20096

Retrospective Cohort

Single center- North America

2001-2008

NR

CT venography or lower extremity venous duplex ultrasonography prior to filter removal only (no surveillance immediately post-op)

NR

Elevation above the normal range of any of the variables associated with thrombophilia (antithrombin III deficiency, protein C deficiency, protein S deficiency, homocysteine elevation, factor V Leiden mutation, presence of anticardiolipin antibodies (immunoglobulins G and M), presence of lupus anticoagulant, those who had strong clinical indicators of high VTE risk including: poor ambulation, history of severe venous stasis disease, pulmonary hypertension, severe sleep apnea with obesity hypoventilation syndrome, BMI over 60, prior VTE

Revisional surgery

IVCF alone

Kardys, C. M. 20087

Retrospective Cohort

Single center- North America

2004-2006

NR

NR

NR

Review of all bariatric patients who underwent IVUS-guided IVCF placement at Roux-en-Y gastric bypass was performed. Patients with a history of VTE, profound immobility, venous insufficiency, hypercoagulable disorder were considered for IVCF placement.

NR

Piano, G., 20078

Prospective Cohort

Single center- North America

2004-2005

NR

One week before filter retrieval, all patients were re-evaluated by the vascular surgeon (G. P.) and underwent venous color-flow duplex ultrasound scanning of the lower extremities to rule out lower extremity DVT

NR

BMI ≥55 kg/m2, previous history of deep venous thrombosis (DVT) or pulmonary embolus, candidates for bariatric surgery, severe immobility, hypercoagulable state, venous stasis

NR

Schuster, R., 20079

Retrospective Cohort

Single center- North America

2003-2006

Follow up was 16 ± 7.6 months (range 8-33)

No

 NR

All patients underwent laparoscopic gastric bypass surgery.

Indications for IVC filter insertion were history of DVT or PE, severe venous stasis disease, long-standing sleep apnea and/or weight >400 pounds



NR

Schweitzer, M., 200610

Case Report

Single center- North America

NR

NR

NR

NR

NR

NR

Vaziri, K., 201011

Retrospective Cohort

Single site- North America

2007-2009

NR

NR

NR

BMI ≥55 kg/m2, bariatric surgery, severe immobility, prior history of VTE, preexisting hypercoaguable disorder

NR

Veerapong, J., 200812

Case report

Single center- North America

NR

NR

NR

NR

NR

NR

Pharmacological versus Pharmacological

Borkgren-Okonek, M. 200813

Non randomized prospective open trial

Single center- North America

2004-2006

3 months post surgery

Lower extremity venous USS, Computed Chest Tomography

Study was an investigator-initiated trial funded in part by a pharmaceutical company

Age≥18 years, patients meeting eligibility criteria established by the NIH and underwent first time RYGB

Creatinine >1.6 mg/dL, previous VTE or known hypercoagulable state, chronic warfarin use, contraindication/hypersensitivity to UFH or LMWH (including a history of heparin-induced thrombocytopenia)

Hamad, G.G., 200514

Retrospective Cohort

Multi center- North America

January 2002- December 2002

NR

Doppler USS, V/Q scan, Chest CT

Funded by an unrestricted educational grant from a pharmaceutical company

All patients satisfied the NIH criteria for bariatric surgery and had undergone a primary bariatric surgical procedure (RYGB, VBG or laparoscopic RYGB)

NR

Kothari, S. 200715

Prospective Cohort

Single center- North America

NR

30 days

NR

NR

Laparoscopic Gastric Bypass patients

NR

Ojo, P., 200816

Retrospective Cohort

Single center- North America

2004-2005

Post-op till 2 weeks after discharge from hospital

NR

NR

Previous history of PE or DVT; BMI≥60; or BMI≥50 with any of these 3 risk factors: venous stasis disease; obstructive sleep apnea or severe ambulation limitation

Patients with previous history of bleeding and those discharged on therapeutic LMWH dosages or warfarin

Raftopoulos, I., 200817

Non randomized trial

Single center- North America

2003-2007

>1month

Pre-hospital discharge bilateral lower extremities venous doppler studies

NR

Patients who underwent bariatric surgery with more than 1 month follow-up

NR

Rowan, B. O. 200818

Prospective Cohort

Single center- North America

2005-2006

NR

NR

NR

Any patient undergoing laparoscopic banding or laparoscopic gastric bypass surgery

All anti-Xa levels drawn earlier than 3hr postdose or later than 5hr postdose

Scholten, D. J.,200219

Retrospective Cohort

Single center- North America

1997-2000

6 months

DVT by USS or venogram

PE by spiral CAT scan



NR

Primary bariatric surgical patients and revisional bariatric surgical patients.

Inpatient death (not due to PE), patients with previous VTE or hypercoagulable state who opted for outpatient prophylactic treatment following hospital discharge

Simone, E. 200820

Prospective Cohort

Single center- North America

2006-2007

Duration of hospital stay

NR

NR

Laparoscopic gastric bypass or laparoscopic adjustable gastric band placement, admission between November 2006-March 2007

Anti-Xa levels were not drawn correctly, withheld enoxaparin because of bleeding concerns

Singh, K., 201121

Retrospective Cohort

Single center- North America

2004-2007

2 years

Venous color Doppler flow, CTA

NR

Patients who underwent Roux-en-Y gastric bypass surgery

NR

AIS= Abbreviated Injury Scale; BMI= Body Mass Index; CAT= Computed Axial Tomography; CT= Computed Tomography; CTA= Computed Tomography Angiography; CUS= Compression Ultrasonography; DVT= Deep Vein Thrombosis; GCS= Glasgow Coma Scale; ICU= Intensive Care Unit; IPG= Impedance Phlebography; ISS= Injury Severity Score; IVC= Inferior Vena Cava; IVCF= Inferior Vena Cava Filter; LE= Lower Extremity; LMWH= Low Molecular Weight Heparin; NIH= National Institutes of Health; NR= Not Reported; PE= Pulmonary Embolism; P-IVCF= Prophylactic Inferior Vena Cava Filter; RCT= Randomized Controlled Trial; R-IVCF= Retrievable Inferior Vena Cava Filter; RYGB= Roux-en-Y gastric bypass; SCD= Sequential Compression Device; SCI= Spinal Cord Injury; TBI= Traumatic Brain Injury; UFH= Unfractionated Heparin; USS= Ultrasound Scan; VCF= Vena Cava Filter; V/Q Scan = Ventilation Perfusion Scan; VTE= Venous Thromboembolism; VBG=Vertical Banded Gastroplasty


Reference List


  1. Van Ha TG, Dillon P, Funaki B et al. Use of retrievable filters in alternative common iliac vein location in high-risk surgical patients. J Vasc Interv Radiol 2011; 22(3):325-9.

  2. Birkmeyer NJ, Share D, Baser O et al. Preoperative placement of inferior vena cava filters and outcomes after gastric bypass surgery. Ann Surg 2010; 252(2):313-8.
    Notes: CORPORATE NAME: Michigan Bariatric Surgery Collaborative

  3. Gargiulo NJ 3rd, Veith FJ, Lipsitz EC, Suggs WD, Ohki T, Goodman E. Experience with inferior vena cava filter placement in patients undergoing open gastric bypass procedures. J Vasc Surg 2006; 44(6):1301-5.

  4. Li W, Gorecki P, Semaan E, Briggs W, Tortolani AJ, D'Ayala M. Concurrent prophylactic placement of inferior vena cava filter in gastric bypass and adjustable banding operations in the Bariatric Outcomes Longitudinal Database. J Vasc Surg 2012; 55(6):1690-5.

  5. Obeid FN, Bowling WM, Fike JS, Durant JA. Efficacy of prophylactic inferior vena cava filter placement in bariatric surgery. Surg Obes Relat Dis 2007; 3(6):606-8; discussion 609-10.

  6. Overby DW, Kohn GP, Cahan MA et al. Risk-group targeted inferior vena cava filter placement in gastric bypass patients. Obes Surg 2009; 19(4):451-5.

  7. Kardys CM, Stoner MC, Manwaring ML et al. Safety and efficacy of intravascular ultrasound-guided inferior vena cava filter in super obese bariatric patients. Surg Obes Relat Dis 2008; 4(1):50-4.

  8. Piano G, Ketteler ER, Prachand V et al. Safety, feasibility, and outcome of retrievable vena cava filters in high-risk surgical patients. J Vasc Surg 2007; 45(4):784-8; discussion 788.

  9. Schuster R, Hagedorn JC, Curet MJ, Morton JM. Retrievable inferior vena cava filters may be safely applied in gastric bypass surgery. Surg Endosc 2007; 21(12):2277-9.

  10. Schweitzer M, Steele KE, Lidor A, Magnuson T. Acute vena cava thrombosis after placement of retrievable inferior vena cava filter before laparoscopic gastric bypass. Surg Obes Relat Dis 2006; 2(6):661-3.

  11. Vaziri K, Devin Watson J, Harper AP et al. Prophylactic Inferior Vena Cava Filters in High-Risk Bariatric Surgery. Obes Surg 2010.

  12. Veerapong J, Wahlgren CM, Jolly N, Bassiouny H. Successful percutaneous retrieval of an inferior vena cava filter migrating to the right ventricle in a bariatric patient. Cardiovasc Intervent Radiol 2008; 31 Suppl 2:S177-81.

  13. 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):625-31.

  14. 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):1368-74.

  15. Kothari SN, Lambert PJ, Mathiason MA. A comparison of thromboembolic and bleeding events following laparoscopic gastric bypass in patients treated with prophylactic regimens of unfractionated heparin or enoxaparin. 2007; 194:709-11.
    Notes: Number of Volumes: 6
    Record Number: 523

  16. Ojo P, Asiyanbola B, Valin E, Reinhold R. Post discharge prophylactic anticoagulation in gastric bypass patient-how safe? Obes Surg 2008; 18(7):791-6.

  17. Raftopoulos I, Martindale C, Cronin A, Steinberg J. The effect of extended post-discharge chemical thromboprophylaxis on venous thromboembolism rates after bariatric surgery: a prospective comparison trial. Surg Endosc 2008; 22(11):2384-91.

  18. 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.

  19. Scholten DJ, Hoedema RM, Scholten SE. A comparison of two different prophylactic dose regimens of low molecular weight heparin in bariatric surgery. Obes Surg 2002; 12(1):19-24.

  20. 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.

  21. Singh K, Podolsky ER, Um S et al. Evaluating the Safety and Efficacy of BMI-Based Preoperative Administration of Low-Molecular-Weight Heparin in Morbidly Obese Patients Undergoing Roux-en-Y Gastric Bypass Surgery. Obes Surg 2011.



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