Evidence Table 32. Study Characteristics KQ6

Evidence Table 32. Study characteristics KQ6 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) IVCF versus IVCF Van Ha, TG, Retrospective Single center- 2005- 10 weeks (4 All patients underwent NR BMI- >50 NR Cohort North America 2008 weeks post venous color-flow duplex kg/m2 placement + ultrasound of the lower One 6 weeks post extremities 1 week before patient retrieval) filter removal to rule out lower undergoin extremity DVT. g removal of a retroperit oneal primitive neuroecto dermal tumor received bilateral iliac filter placemen t not because of megacav a, but to prevent potential surgical field disruption caused by IVC placemen t. All patients underwen t full assessm ent and informed consent for retrievabl e filter placemen t and subseque nt retrieval. IVCF versus Control Birkmeyer, N. Retrospective Multi- center- 2006- NR NR Longitudinal Open or Revisional surgery, Cohort North America 2008 laparosco laparoscopic gastric pic banding, biliopancreatic gastric diversion, sleeve bypass gastrectomy procedures procedur e IVCF versus Control

E-1 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) Gargiulo, N.J., Ambidirectional- Single center- 1999- NR DVT: All patients had routine NR NR NR Retrospective- North America 2005 pre and post-operative lower Prospective extremity venous duplex Cohort 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) Retrospective Multi- center- 2007- 90 day post NR Surgical Review Patients NR Cohort North America 2009 operative Corporation undergoin follow-up visit g Roux- information en-Y was collected gastric bypass and adjustabl e gastric banding surgeries. Obeid, F. N., Retrospective Single center- 2000- NR NR NR NR NR Cohort North America 2006 Overby, D. W., Retrospective Single center- 2001- NR CT venography or lower NR Elevation Revisional surgery Cohort North America 2008 extremity venous duplex above the ultrasonography prior to filter normal removal only (no surveillance range of immediately post-op) any of the variables associate d with thrombop hilia (antithro mbin III deficiency , protein C deficiency , protein S deficiency , homocyst eine elevation, factor V Leiden mutation, presence of anticardio lipin antibodie s (immunog lobulins G E-2 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) and M), presence of lupus anticoagu lant, those who had strong clinical indicators of high VTE risk including: poor ambulatio n, history of severe venous stasis disease, pulmonar y hypertens ion, severe sleep apnea with obesity hypoventi lation syndrome , BMI over 60, prior VTE

Retrospective Single center- 2004- NR NR NR Review of NR Kardys, C. M. Cohort North America 2006 all bariatric patients who underwen t IVUS- guided IVCF placemen t at Roux- en-Y gastric bypass was performe d. Patients with a history of VTE, profound immobility , venous E-3 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) insufficien cy, hypercoa gulable disorder were considere d for IVCF placemen t. Prospective Single center- 2004- NR One week before filter NR BMI ≥55 NR Cohort North America 2005 retrieval, all patients were re- kg/m2, evaluated by the vascular previous surgeon (G. P.) and history of underwent venous color-flow deep duplex ultrasound scanning venous of the lower extremities to thrombosi rule out lower extremity DVT s (DVT) or pulmonar y embolus, candidate s for bariatric surgery, severe immobility , hypercoa gulable state, venous stasis Retrospective Single center- 2003- Follow up No NR All NR Schuster, R., Cohort North America 2006 was 16 ± 7.6 patients months underwen (range 8-33) t laparosco pic gastric bypass surgery. Indication s for IVC filter insertion were history of DVT or PE, severe venous stasis disease, long- standing sleep E-4 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) apnea and/or weight >400 pounds Case Report Single center- NR NR NR NR NR NR Schweitzer, M., North America

Retrospective Single site- North 2007- NR NR NR BMI ≥55 NR Cohort America 2009 kg/m2, bariatric surgery, severe immobility , prior history of VTE, preexistin g hypercoa guable disorder Case report Single center- NR NR NR NR NR NR Veerapong, J., North America

Pharmacological versus Pharmacological Non randomized Single center- 2004- 3 months Lower extremity venous USS, Study was an Age≥18 Creatinine >1.6 mg/dL, prospective North America 2006 post surgery Computed Chest investigator- years, previous VTE or known open trial Tomography initiated trial patients hypercoagulable state, funded in part by meeting chronic warfarin use, a pharmaceutical eligibility contraindication/hyperse company criteria nsitivity to UFH or establish LMWH (including a ed by the history of heparin- NIH and induced underwen thrombocytopenia) t first time RYGB Hamad, G.G., Retrospective Multi center- North January NR Doppler USS, V/Q scan, Funded by an All NR Cohort America 2002- Chest CT unrestricted patients Decemb educational grant satisfied er 2002 from a the NIH pharmaceutical criteria for company bariatric surgery and had undergon e a primary bariatric surgical procedur e (RYGB, VBG or laparosco pic

E-5 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) RYGB) Prospective Single center- NR 30 days NR NR Laparosc NR Cohort North America opic Gastric Bypass patients Ojo, P., 200816 Retrospective Single center- 2004- Post-op till 2 NR NR Previous Patients with previous Cohort North America 2005 weeks after history of history of bleeding and discharge PE or those discharged on from hospital DVT; therapeutic LMWH BMI≥60; dosages or warfarin or BMI≥50 with any of these 3 risk factors: venous stasis disease; obstructiv e sleep apnea or severe ambulatio n limitation Raftopoulos, I., Non randomized Single center- 2003- >1month Pre-hospital discharge NR Patients NR trial North America 2007 bilateral lower extremities who venous doppler studies underwen t bariatric surgery with more than 1 month follow-up Rowan, B. O. Prospective Single center- 2005- NR NR NR Any All anti-Xa levels drawn Cohort North America 2006 patient earlier than 3hr undergoin postdose or later than g 5hr postdose laparosco pic banding or laparosco pic gastric bypass surgery

E-6 Author, Year Study Design Study Site – Recruit Planned Method of Surveillance for Funding Source Inclusion Exclusion Criteria Study Locations ment Length of VTE Criteria Date Follow-up (start date – end date) Retrospective Single center- 1997- 6 months DVT by USS or venogram NR Primary Inpatient death (not due Cohort North America 2000 bariatric to PE), patients with PE by spiral CAT scan surgical previous VTE or patients hypercoagulable state and who opted for outpatient revisional prophylactic treatment bariatric following hospital surgical discharge patients. Prospective Single center- 2006- Duration of NR NR Laparosc Anti-Xa levels were not Cohort North America 2007 hospital stay opic drawn correctly, gastric withheld enoxaparin bypass or because of bleeding laparosco concerns pic adjustabl e gastric band placemen t, admissio n between Novembe r 2006- March 2007 Retrospective Single center- 2004- 2 years Venous color Doppler flow, NR Patients NR Cohort North America 2007 CTA who underwen t Roux- en-Y gastric bypass surgery 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

E-7 Reference List

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