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Welcome to IM Department Meeting! Gadolinium Based Contrast Exposure and Risk of Nephrogenic Systemic Fibrosis Tonights Facilitators: Barbara Doerr, DO.

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Presentation on theme: "Welcome to IM Department Meeting! Gadolinium Based Contrast Exposure and Risk of Nephrogenic Systemic Fibrosis Tonights Facilitators: Barbara Doerr, DO."— Presentation transcript:

1 Welcome to IM Department Meeting! Gadolinium Based Contrast Exposure and Risk of Nephrogenic Systemic Fibrosis Tonights Facilitators: Barbara Doerr, DO William Myers, DO Staci Smith, DO Michelle Cacek, DO

2 Nephrogenic Systemic Fibrosis (NSF) ooriginally named nephrogenic fibrosing dermopathy (NFD) omanifestations initially thought to be confined to the skin osystemic fibrosis on autopsy (NSF) oskeletal muscles,diaphragm,pleura,dura mater, pericardium & myocardium

3 Nephrogenic Systemic Fibrosis (NSF) opredominately in pts with acute kidney injury or severely impaired renal function oCrCl less than 30 ono predilection for age, race, gender,or location otypically middle aged pts oreported in 8 yo children, as well as elderly

4 Whats the risk? orisk of NSF estimated at 4.3 cases per 1,000 dialysis patients per year oabout 2.4 % for each time a CKD pt is exposed to gadolinium obalancing benefit and risk omajority of pts who receive Gd do not develop NSF

5 Whats the issue with NSF? oavoidance of GBCAs olimited radiological studies oroadblocks to specific dx olitigation opportunities

6 September 12, 2007

7 Boxed Warning oGadolinium based contrast agents increase risk of NSF in pts with: oacute and chronic renal failure (GFR < 30) oacute renal insuffciency of any severity due to hepatorenal syndrome or in perioperative liver transplant period

8 What is Gadolinium? ononionic, hyperosmolar (650 mosmol/kg) contrast agent ometal with powerful magnetic properties ocontrast for MR imaging or MR angiography ochelates are excreted exclusively by the kidney

9 Gadolinium Half Life o1.3 hrs if healthy o10 hrs at GFR of mL/min o34 hrs if ESRD o hrs if HD follows administration

10 Gadolinium Based Contrast Agents oOmniscan olaunched in the U.S. in 1993 by GE oMagnevist oMultiHance oOptiMARK oProHance

11 Risk factors for NSF orenal impairment ohypercoagulable state othrombotic events orecent vascular study otransplant failure

12 Signs and Symptoms of NSF oburning skin oitchy skin oswelling otight and hard skin ored or dark skin patches ocontractures ostiffness in joints otrouble moving extremities opain deep in the bones omuscle weakness owoody feel of skin oyellow scleral plaques

13 NSF Upper Extremity othick, hardened skin obrawny hyperpigmentation odistinct papules osubcutaneous nodules

14 NSF Upper Extremity osoft-tissue swelling oflexion contractures of hand

15 oslightly raised and erythematous nodular plaques olinear, confluent regions of fibrosis NSF

16 Differential Diagnosis oscleroderma / systemic sclerosis oeosinophilic fasciitis oeosinophilia–myalgia syndrome

17 Differential Diagnosis oUnlike scleroderma oNSF spares the face olacks the serologic markers of scleroderma osymmetrical lesions oprefers trunk and extremities

18 Punch Biopsy : Skin widening of subcutaneous septae w/ thick collagen bundles

19 Histological Findings and Pathogenesis othick collagen bundles with surrounding clefts omucin deposition oincreased fibrocytes and elastic fibers oincreased factor XIIIa and mononucleated cells

20 Topic Development: PICO oP Patient Population oI Intervention or Exposure oC Comparison Intervention oO Outcome

21 Question ??? oWhat degree of kidney disease should we not use gadolinium based contrast agents ?

22 Article oNephrogenic Fibrosing Dermopathy/ Nephrogenic Systemic Fibrosis: Report of a New Case with Literature Review oDaram, et al. AJKD, Vol 46, No 4, 2005, pp

23 Evidence Based Medicine oNephrogenic Fibrosing Dermopathy /Nephrogenic Systemic Fibrosis: Report of a New Case with Literature Review oDaram,et al. oAJKD 2005

24 Introduction- NSF: Report of a New Case ofirst cases of NSF recognized in 2000 orenal dysfunction pts oregardless of cause onot just HD pts, PD pts as well oother associations: ovascular sx ovascular thrombosis oscleral plaques

25 The Patient: NSF: Report of a New Case o39 yo AAM oESRD on HD d/t HTN for 8 yrs omultiple medical problems oantiphospholipid ab syndrome ono other rheumatologic history o3 yrs before hospital admission ostiff fingers and arms othickening skin on calves and thighs orapid progression to contractures

26 The Patient- NSF: Report of a New Case opts lab data -p 755 ofibrosis around translumbar HD cath opt expired after 45 min of ACLS oautopsy results oextensive fibrosis oplaque like changes across chest, extremities ocontractures othickened pleura odense collagenous bands ofibrotic cardiac tissue

27 NSF: Report of a New Case otaut, waxy appearance ocobblestone pattern ofig 1B

28 NSF: Report of a New Case ochest wall w/thick dermis odense white fibrous bands in septa

29 NSF: Report of a New Case haphazardly arranged collagen bundles w/ clefts

30 NSF: Report of a New Case odiaphragm section ofibrous bands ofibroblast like cells

31 NSF: Report of a New Case dendritic projections on CD34 cells CD45 RO cells

32 Discussion- NSF: Report of a New Case oNFD is not merely a cutaneous disease osystemic manifestations omuscle, pleura, diaphragm, myo and pericardium oinitiating factors in NSF otissue injury ohypercoagulable state

33 Discussion - NSF: Report of a New Case oNSF involves aberrant fibrocyte recruitment odecrease EPO due to fibrogenic properties oNO consistent treatment proven effective

34 Article oNephrogenic Systemic Fibrosis After Exposure to Gadolinium in Patients with Renal Failure oOthersen, J. et al, Nephrology Dialysis Transplantation, Sept 21, 2007, p 1-7.

35 Evidence Based Medicine oNephrogenic Systemic Fibrosis After Exposure to Gadolinium in Patients with Renal Failure

36 NSF After Gadolinium Exposure oPurpose: oanalyze NSF incidence oassociation of NSF with gadolinium exposure in CKD pts oboth pre-dialysis and dialysis pts odetermine if increased gadolinium exposure increases NSF

37 NSF After Gadolinium Exposure oMethods: o849 total pts in 5 yr time span ( ) oNephrology at Medical University of SC odiscussed with Dermatology ostratified by gadolinium exposure o0, 1, or greater than 1 ostatistical association between NSF rate and gad exposure ostatistical association of increasing gad exposure and NSF occurrence

38 NSF After Gadolinium Exposure oMethods: oCKD pts NOT on dialysis o592 pts or 4% had CKD 3 – 4 o6,636 total pts received gad from oskin bx w/ immunoperoxidase staining for CD 34

39 NSF After Gadolinium Exposure oResults: o849 total pts o261 had 354 MRI scans ow/ gadolinium (Omniscan) o1 time exposure in 191 pts o2 exposures in 53 o3 exposures in 13 o4 exposures in 5

40 NSF After Gadolinium Exposure Gadolinium ExposureNSF Incidence Never0% One time1.1% Greater than one time2.9%

41 NSF After Gadolinium Exposure oResults: Pts on Dialysis ooverall NSF rate 0.5% (4 of 261) o1.5% risk of NSF after one gad exposure o98.5% did not develop NSF oodds ratio 6.67 w/ one exposure o44.5 odds ratio with multiple exposures oskin lesions appeared within 2-3 mo ostrong statistical association with NSF and gadolinium exposure

42 NSF After Gadolinium Exposure oResults : CKD 3 – 4 pts ono patients discovered to have NSF oincidence estimated at <0.2% opossibly due to only 4% have CKD 3-4

43 NSF After Gadolinium Exposure oConclusions: oNSF incidence is very low oincreased exposure leads to increased risk ohigher Ca, Phos, and Epo may be associated with increased NSF incidence oNO need for gad restriction in CKD 3- 4 omonitor skin for 4-6 mo if gad is used oconsider dialysis immediately after exposure okidney transplant therapy in future

44 Concluding Points oA oAcademic Detailing oR oReminders oE oEnticements oA oAudit

45 Concluding Points: Academic Details oAcademic Detailing: oMedical knowledge oNSF oPatient care oCommunication oOMM/OPP oSystems based practice oPhysician interacts with healthcare system oPractice based learning oPhysicians maintain knowledge and skills to provide ongoing pt care

46 Osteopathic Considerations omyofascial release oindirect techniques owhole body approach

47 Osteopathy in Action oNSF registry ocollects info about NSF pts from all over the world oGeneral Clinical Research Center at Yale University o oCDC owww.cdc.gov oFDA o1-800-FDA-1088 owww.FDA.gov

48 Systems Based Practice oacute NSF: ochronic NSF: 5829 oinclude CKD staging: oprincipal procedure oMRI imaging: 8897

49 Systems Based Practice oCerebral a. occlusion w/ cerebral infarction DRG: $5, Medicare oCerebral a. occlusion w/ cerebral infarction plus acute NSF DRG: 43491, $7, Medicare

50 Reminders oCarepath in future oscreening baseline kidney fxn / size oacute kidney injury vs CKD oCrCl –when not to use gadolinium ofollow-up labs after gadolinium use owhen to dialyze ESRD pts if GBCA used

51 Enticements/ Systems Based Practice oMRI imaging: DRG 8897 oMRI brain w/ contrast: $3,692 oMRI brain w/o contrast: $2,255 oMRI thoracic/lumbar spine w/ contrast : $2,465 oMRI thoracic/lumbar w/o contrast: $2,144

52 Audit oHow can we measure outcomes and progress? oPractice habits changed in the future?

53 Conclusions : Take Home Points ointerest of pt safety obalance benefits and risks of GBCAs oscreen all pts with labs and history oGBCAs should NOT be used if CrCl <30 ocareful consideration if CrCl <60 oalternative imaging methods

54 Conclusions: Take Home Points omonitor for skin manifestations after GBCA ofollow labs after administration odo not exceed recommended dose o mmol/kg oallow time for elimination before readministration

55 Please Join Us Next Month oIM Journal Club opresented by Dr. Bryan olaryngeal reflux and proton pump inhibitors

56 References oNephrogenic Fibrosing Dermopathy /Nephrogenic Systemic Fibrosis: Report of a New Case with Literature Review.Daram,et al. AJKD oNephrogenic Systemic Fibrosis After Exposure to Gadolinium in Patients with Renal Failure. Othersen, J. et al, Nephrology Dialysis Transplantation, Sept 21, 2007, p 1-7.

57 Happy Halloween !! Trick or treat

58 References Gadodiamide-Associated Nephrogenic Systemic Fibrosis: Why Radiologists Should Be Concerned. Dale R. Broome et al. AJR 2007; 188: Adverse Reactions to Gadolinium Contrast Media: A Review of 36 Cases. Murphy,et al. AJR, Oct 1996:


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