Where Does it Fit in Foot and Ankle Surgery? · – DVT screening with color duplex sonography was conducted 3 weeks and 6 weeks after surgery – Intervention was placebo or dalteparin

American College of Foot and Ankle Surgeons

Research and Evidence-Based Medicine Committee: 2007

ACFAS.orgFootPhysicians.com

Evidenced-Based Medicine:Where Does it Fit in Foot

and Ankle Surgery?MODULE: DVT PROPHYLAXIS

Jarrett D. Cain, DPM, AACFASRosalind Franklin University School of Medicine and Sciences

North Chicago, Illinois




Evidence-Based Medicine

The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of the individual patient

It means integrating individual clinical expertise with the best available external clinical evidence from systematic research

Dr. David Sackett, 1996




Evidence-Based Medicine

Clinical Expertise

Patient Values Best Evidence

Patient Care




Fundamental Principles

Evidence is never enoughHierarchy within EBM




Steps In EBM Process

Clinical ProblemQuestionResourceEvaluationPatient




Asking the Question

Foreground Question

Background Question

Novice Expert




Meta-Analysis

Systematic Review

Randomized Controlled Trial

Cohort Studies

Case Control Studies

Case Series/Case Reports

Animal Research/Laboratory Studies

Hierarchy of EBM




“P.I.C.O.”

Patient + ProblemInterventionComparisonOutcome




Levels of Evidence

January 2003• Journal of Bone and Joint Surgery American

February 2005• American Academy of Orthopaedic Surgeons




JBJS Am:Levels of Evidence

I, II, III, IV, V based on designTypes • Therapeutic• Prognostic• Economic• Decision Analysis




JBJS Am:Levels of EvidenceRandomized Control Trial: Prospective• Level I or IICohort: Prospective comparative study• Level II or IIICase Control: Retrospective study• Level IIICase Series• Level IVExpert Opinions• Level V




Grades of RecommendationGrade A• Treatment options supported by strong evidence• Level I or II studies

Grade B• Treatment options supported by fair evidence • Level II or III studies

Grade C • Treatment options supported by either conflicting or poor

quality evidence • Level III or IV studies

Grade I• Insufficient evidence exists to make recommendation




Journal of Bone and Joint Surgery Am + BrJournal of Orthopaedic TraumaJournal of Shoulder and Elbow SurgeryAmerican Journal of Sports MedicineJournal of Prosthetics and OrthoticsFoot and Ankle InternationalJournal Hand SurgeryJournal of Athroplasty JBJS 87A(12), 2005




Levels of Evidence

0

10

20

30

40

50

60

70

80

Level I Level II Level III Level IV

Am J Sports Med

FAI

J Arthroplasty

JBJS Am

JBJS Br

J Hand Surg

JOT

JPO

J Shoulder/Elbow

JBJS 87A(12), 2005




Levels of Evidence

0

10

20

30

40

50

60

Level ILevel IILevel IIILevel IV

JBJS 87A(12), 2005




Evaluation of the Foot and Ankle Literature

Journal Foot and Ankle SurgeryFoot and Ankle International




Evaluation of the Literature

Jan/Feb 2005 –Jan/Feb 2007

• 157 Articles• 3 RCT





January 2005 –January 2007

• 387 Articles• 4 RCT





“Target your reading to particular issues related

to the patient”




EBM Literature Sources

Cochrane Database: http://www.cochrane.org/

Medline: http://www4.infotrieve.com/newmedline/search.asp

UpToDate: http://www.uptodate.com/

Best Evidence: http://www.cebm.net/searching.asp

OVID: http://www.ovid.com/site/index.jsp




AGAINST FOR

“Old Hat”Cook Book MedicinePopulation StudiesLack of Gold StandardAccess Difficulty

Strong EvidenceOne PartPatient DecisionEvidence PyramidTrained Professionals




MODULE: DVT prophylaxis59 year old female presents with a painful

neuroma in the 3rd interspace of the left foot-patient desires surgical correction of her condition

PMH: high cholesterol, varicose veins; no history of blood clots

Meds: LipitorAllergies: NKDASocial History: h/0 EtOH useFamily History: no family history of DVTs/PE




??Treatment Options??

• Surgical correction• Excision of neuroma

•• No DVT prophylaxisNo DVT prophylaxis•• DVT prophylaxis DVT prophylaxis

•• AspirinAspirin•• HeparinHeparin•• Low Molecular Weight HeparinLow Molecular Weight Heparin•• CoumadinCoumadin




ConcernsSurgical excision without DVT prophylaxis• DVT may present significant challenge in certain

orthopedic procedures• Can lead to PE which may lead to death

Surgical excision with DVT prophylaxis• Increase chance of post-operative bleeding• Increase skin ecchymosis




Concerns

Question• SHOULD WE PROVIDE

PROPHYLACTIC TREATMENT FOR SUCH A MINOR FOOT PROCEDURE?




What does the literature say?Foot surgery with DVT prophylaxis• Mizel M. et al, CORR March 1998 (EBM Level IV)

–– 2733 pts evaluated2733 pts evaluated–– 0.22% DVT; 0.15% nonfatal pulmonary emboli0.22% DVT; 0.15% nonfatal pulmonary emboli–– Factors for DVT included NWB status and immobilizationFactors for DVT included NWB status and immobilization–– Routine prophylaxis is not warranted Routine prophylaxis is not warranted

• Solis S. et al, Foot and Ankle International 2002 (EBM Level IV)– 201 patients evaluated after foot and ankle surgery– Ultrasound performed from popliteal vein during first post operative visit– DVT found in 7 pts (3.5%) with none progressing during the post op

course– Rate and progression of DVT after surgery is low and does not require

routine prophylaxis




What does the literature say?Foot Surgery with DVT prophylaxis• Radl R et al., JBJS-A 2003( EBM Level II)

–– 100 consecutive pts who underwent hallux valgus surgery and 100 consecutive pts who underwent hallux valgus surgery and did not receive medical prophylaxisdid not receive medical prophylaxis

–– Pts with clinical/hematological risk factors for DVT were Pts with clinical/hematological risk factors for DVT were excludedexcluded

–– Evaluated 29 days postEvaluated 29 days post--op with phlebographyop with phlebography–– 4% pts developed venous thrombosis4% pts developed venous thrombosis–– Concluded pts who undergo hallux valgus surgery is at low risk Concluded pts who undergo hallux valgus surgery is at low risk

and routine prophylaxis and routine prophylaxis mightmight be justified in pts over 60be justified in pts over 60




What does the literature say?Foot surgery with DVT prophylaxis• Hanslow et al., Foot Ankle Int 2006 (EBM Level IV)

–– Retrospectively reviewed 602 foot/ankle surgery patients Retrospectively reviewed 602 foot/ankle surgery patients for risks factors associated with DVTfor risks factors associated with DVT

–– 24 patients(4%) had post op thromboembolic events24 patients(4%) had post op thromboembolic events–– Risk factors included: RA, h/o air travel, previous DVT Risk factors included: RA, h/o air travel, previous DVT

or PE, immobilizationor PE, immobilization–– Prospective RCT are needed to establish true incidence Prospective RCT are needed to establish true incidence

and define indications for prophylaxisand define indications for prophylaxis




What does the literature say?Foot Surgery with DVT prophylaxis• Lapidus et al, Journal of Ortho Trauma, Jan. 2007 (EBM

Level I)–– RCT double blind study of 105 consecutive surgically treated RCT double blind study of 105 consecutive surgically treated

Achilles tendon rupturesAchilles tendon ruptures–– DVT screening with color duplex sonography was conducted 3 DVT screening with color duplex sonography was conducted 3

weeks and 6 weeks after surgeryweeks and 6 weeks after surgery–– Intervention was placebo or dalteparin (5000 U) given Intervention was placebo or dalteparin (5000 U) given

subcutaneously once daily for 6 weeks postoperativelysubcutaneously once daily for 6 weeks postoperatively–– 16/47 in dalteparin group; 16/44 in placebo group had diagnosed 16/47 in dalteparin group; 16/44 in placebo group had diagnosed

DVTDVT–– DVT is common after surgical treatment of achilles tendon DVT is common after surgical treatment of achilles tendon

rupture and effective thromoboprophylaxis is desirablerupture and effective thromoboprophylaxis is desirable




What does the literature say??Foot surgery with DVT prophylaxis• Gadgil A., Foot Ankle International 2007 (EBM

Level V)–– Survey of American and British foot and ankle Survey of American and British foot and ankle

surgeonssurgeons–– 31% response rate (140 out of 455)31% response rate (140 out of 455)–– Only 19%(27/140) routinely used prophylaxis in Only 19%(27/140) routinely used prophylaxis in

trauma or elective foot and ankle surgery.trauma or elective foot and ankle surgery.most commonmost common--elective hindfoot, ORIF ankle, and trauma elective hindfoot, ORIF ankle, and trauma treated with conservative with NWB in a plastar casttreated with conservative with NWB in a plastar cast




Review

Based on the literature:• Prophylaxis is not needed for minor foot and ankle

procedures




ReviewHowever based on critical review of the literature:• Studies focused on elective foot surgery were EBM Level IV• Not enough EBM Level I or II studies to establish a

treatment protocol of DVT prophylaxis• No standard to the surgeons’ approach to determining if pts

had DVT• Inconsistencies in the inclusion/exclusion criteria• Greater need for larger multi-center studies to clarify rate

and risk observed in high risk subjects




Foot Surgery with DVT prophylaxis

Grade C Recommendation:• Treatment options are supported by conflicting or

poor quality evidence




My treatmentPatient underwent excision of neuroma of the left foot• Patient did not have DVT prophylaxis of any form• Patient was immobilized in a dressing of the left

foot and was limited weightbearing in a surgical shoe

• During the postop course, patient had painful swollen left calf. After being sent to the ER, patient had developed of the left popliteal vein which was diagnosed by ultrasound.




Where Does EBM Fit with Foot and Ankle Surgery??




Where Does EBM Fit ?

ACFASResearchEBM ONLY??Your Step




THANK YOU !

Documents

Where Does it Fit in Foot and Ankle Surgery? · – DVT screening with color duplex sonography was conducted 3 weeks and 6 weeks after surgery – Intervention was placebo or dalteparin