Christopher Bajzer, M.D.

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1 Carotid Stenting for Carotid Artery Disease Christopher, M.D. Coronary and Peripheral Vascular Intervention The Cleveland Clinic Cleveland, Ohio, U.S.A. Cleveland Clinic Heart and Vascular Institute 22 August 2010

2 Carotid Stenting in 2010 CMS Indications > 80% ICA stenosis Symptoms causally related to ipsilateral carotid stenosis High surgical risk (age > 80, AP CC 3-4, NYHA FC 3-4, need for OHS, prior neck surgery, severe lung disease, severe AS, low LVEF Must use EPD Other approved indications in the U.S. None outside of a clinical trial Clinical trials exist for Asymptomatic, >80%, usual surgical risk Asymptomatic, >80%, high surgical risk Symptomatic, >80%, usual surgical risk

3 Why Carotid Stent Revascularization is driven by stroke reduction Stenting is more Patient driven Follows unstoppable tide of movement towards less invasive intervention or surgery with quick resumption of usual ADL s Eliminate anesthesia risk Eliminate nerve palsy In US trials - Clinical equivalence with CEA

4 Obstacles to Carotid Stenting Re-imbursement issues CMS and zero-sum budgets Access to Clinical Trial sites Physician variables Bias to open surgery Knowledge/awareness Pendulum swing to re-examine best medical therapy

5 Carotid Stent Clinical Trials Challenges Today Successful operators Mandatory follow-up Standardized quarterly reporting to CMS (SCAI, SVS) $ Confirmations EPD s are a must Equivalence with CEA in US trials Restenosis data replicated repeatedly at 1% per year or less advantage over CEA Risk highest in ESRD on HD and extreme old age

6 Prior Right CEA with vein patch Prior Left CEA complicated by vocal cord paralysis Right Common Carotid stenosis 80-99% by Duplex RICA 40-59% by Duplex Type I arch Case 1

7 Case 1: Intracranial Views

8 6F 90 cm Shuttle in position How to get an EPD into position? Used 5 F JR4 Guide placed within the patch over BHW as buddy to place the EPD Case 1: EPD

9 Case 1: Good Stent 10 x 20 stent Post-dilate 6 x 20 balloon Good result

10 Case 1: Good Result EPD removed with visible debris in filter Final intracranial view shows improved flow Trial patient with good result

11 Case 2: Decision 65 year old man Risk factors: diabetes, hyperlipidemia, hypertension, tobacco 3 vessel CAD slated for surgery - asymptomatic from coronary standpoint TIA: Left arm and leg weakness - complete resolution Duplex carotids: Right 80-99% carotid stenosis; Left 60-79% stenosis

12 Plan for CS with EPD then CABG after 4 weeks Arch is type I - straight-forward carotid access What is distal to the stenosis? Case 2: Plan? Pre2DSA - avi

13 Previous projection and Non-subtracted view demonstrates severe tortuosity = sink trap anatomy downstream of stenosis Reconsider strategy? Case 2: Decision Pre2 - avi

14 8F H1 guide for adequate back-up support Buddy wire (BMW) placed first to best define anatomy and potentially straighten curves Case 2: Forward Wire static

15 Case 2: Problem EPD will not negotiate even the first curve But, appear to have adequate landing zone for balloons and stent before the EPD Pre-dilate 4 mm x 20 mm balloon Balloon static

16 Stent placed No Flow! Case 2: Big Problem Patient unable to move left arm or leg and has word apraxia What to do? NoFlow - avi

17 Quickly post-dilate stent with 5.5 mm x 20 mm balloon Ready aspiration catheter for aspiration runs Case 2 Posting static

18 3 aspirations runs with export catheter Sandy material recovered in all 3 aspiration runs - largest volume in 2nd run Case 2 Aspirate static

19 Case 2: Improved flow Pre Rt IC static Post Rt IC static

20 Case 2: Questionable Stent 20 minutes after flow is restored, patient is back to baseline without any neurologic deficits Anatomy sometimes trumps clinical scenario Final - avi

21 Case 3 67 y.o. woman referred by interventional colleague Heavy smoker CAD s/p PCI for recent STEMI Asymptomatic Screening Duplex PSV = 695; EDV 303; Ratio 16 DuplexPre.Dopp

22 Case 3: Decision time Asymptomatic from carotid standpoint 2D Longitudinal view on duplex Distal vessel NOT described as string Is this carotid in need of revascularization? PSV = 695; EDV 303; Ratio 16

23 Case 3: Another Decision Referring colleague and patient wish to proceed with angio and endo revasc Arch Is that LICA in need of revascularization?

24 Selective of LICA Case 3

25 Intracranial view of Left carotid injection Case 3 FinalDSA - avi

26 Case 3 Lateral view in motion

27 Here we go Case 3: Down a Path Only Whisper wire can cross not EPD Small balloon first to facilitate EPD

28 EPD crosses Additional dilation with 4.0 balloon 7-10/30 tapered stent posted with 5.0 balloon Pretty reasonable result ICA not plump Case 3

29 Intracranial Final Patient and family and referring MD all very happy Case 3

30 Case 3: Wrong Decision Asymptomatic post procedure Ready to go home Duplex shows Closed Carotid Stent Not every stenosis needs revascularization

31

32 Plan for CS with EPD then CABG after 4 weeks Arch is type I - straight-forward carotid access Angiogram of RICA Where is stenosis? Case 2: Plan Pre - avi

33 Intra-cranial flow from right carotid injection Very slow filling of right MCA only Isolated hemisphere Case 2: Plan? Reconsider strategy? RtICPre - avi

34 Position stent Note that stent nose cone encroaches on back marker of EPD Case 2 PositStent1 - avi

35 Case 2 Stent repositioned Note slow flow Concern? Due to equipment occupying space in artery? Filter filling with particles? Particles slipped past filter? PositStent2 - avi

36 EPD recovered and flow restored Case 2 Flow - avi

37 Case 2 Patient still symptomatic What do we do? FlowDSA - avi

38 Intra-cranial flow improved without any vessel cut-off? Case 2:? PostRtIC - avi

39 Nitroglycerin 150 micrograms infused Angiogram repeated Still questionable in more that one view What to do? Case 2 FinalDSA - avi

40 Stepping through the images in more than one view No flow limiting tear or obvious dissection Some spasm persists Mandible gives some subtraction artefact Some residual disease proximal as well Case 2 Final1 static

41 Post-stent duplex reveals marked reduction in velocities to 0-19% range Tortuosity visualized No tear nor dissection seen Case 2 Final2 static

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