Step-by-step Approach to Paravalvular Leak Closure

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1 Transcatheter Valve Therapies TVT Seattle, USA, June 2-5, 2012 Step-by-step Approach to Paravalvular Leak Closure - Including Case Presentations - Horst Sievert, Ilona Hofmann, Undine Pittl, Laura Vaskulite CardioVascular Center Frankfurt, Frankfurt, Germany

2 Conflict of Interest Statement Physician name Company Horst Sievert Abbott, Access Closure, AGA, Angiomed, Aptus, Ardian, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Cardiac Dimensions, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, CVRx, EndoCross, EndoTex, Epitek, Evalve, ev3, FlowCardia, GDS, Gore, Guidant, InSeal Medical, Lumen Biomedical, HLT, Kensey Nash, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, OAS, Occlutech, Osprey, Pathway, PendraCare, Percardia, pfm Medical, ResMed, Rox Medical, Sadra, Sorin, Spectranetics, SquareOne, Trireme, Trivascular, Velocimed, Veryan, Vessix Cardiokinetix, Access Closure, Lumen Biomedical, Coherex Relationship Consulting fees, Travel expenses, Study honoraria Stock options, Stocks

3 Before the Procedure Clinical exam, TTE, Chest X-ray Blood tests - Hemoglobin, LDH Degree of hemolysis? - Leucocytes, CRP Endocarditis? Endocarditis prophylaxis General anesthesia stand-by TEE - always for mitral leaks - stand-by for aortic leaks Heparin 5,000-10,000

4 Devices Amplatzer VSD Occluder PDA Occluder

5 Amplatzer Vascular Plug Amplatzer Vascular Plug (AVP) AVP Diameter: 4-16 mm Length: 7-8 mm Compatible sheath: 5-8 Fr Amplatzer Vascular Plug II (AVP-II) AVP-II Diameter: 3-22 mm Length: 6-18 mm Compatible sheath: 5-8 Fr Occludes twice faster than AVP

6 Device should match the anatomy! Round oval crescentic Slit-like Crescentic cutting edge

7 Amplatzer Vascular Plug III Oval-shaped Thinner wires More wires Multiple layers smaller pore size improved surface contact faster occlusion

8 AMPLATZER Vascular Plug Diagnostic Catheter Floppy Delivery Wire Tip Short Landing Zone

9 Aortic Paravalvular Leaks Less frequent than mitral leaks (~ 5% vs ~12%) Symptoms often less severe than in mitral paravalvular leaks Most frequently posterior of the valve Often very close to the valve May be round but most often crescent-shaped During systole there is no gradient across the leak During diastole aortic pressure > LV pressure - Device embolization into LV is more likely than embolization into the aorta

10 How to Close? Vascular access - Femoral Measure the distance between groin and valve - Is the sheath long enough? - Or is brachial access needed? - Brachial Advantage: the sheath will be long enough Disadvantage: some X-ray projections may be difficult - Transseptal Rarely needed for para-aortic leaks - Trans-apical If other techniques fail Or as primary approach?

11 How to Close? Locate the defect in TEE - Adjust the image intensifier accordingly - Selective angiogram Pig-tail or Multipurpose or FR4 30 Image intensifiyer 30 LAO

12 Aortogram with image intensifyer adjusted according to TEE images

13 How to Close? Cross the leak with - 5F diagnostic cath " hydrophilic wire Long sheath F - Hydrophilic Orthogonal view of the valve Check the motion of the valve leaflets Device implantation Check valve leaflet motion again before device release

14 Case 1 27 mm Medtronic Hall Orthogonal view Optimal projection for Muscular VSD Occluder

15 Case 2 Paravalvular leak at 9 o'clock

16 Case 2 Crossing with right coronary Judkins catheter

17 No Case 2 7F-Cook-Shuttle sheath Implantation of a 14/5mm AVP III occluder

18 Case 2 No relevant residual leak

19 Case 3 72 y old male patient Dilated CMP (EF 20%) Aortic valve replacement paravalvular leaks (first diagnosed in 1995) Recurrent cardiac decompensation

20 Case 3 TEE: Paravalvular leaks in SAX and LAX views

21 Case 3 Not possible to introduce a 8F sheath but a 8F guiding catheter 14/5 mm AVPIII occluder- Opening of LV disc Deployment of occluder

22 Case 3 Check with contrast injection Release of occluder

23 Case 3 Final result in 3D TEE No interference with the Valve Small residual shunt beneath occluder

24

25 How to Approach Mitral Valve Leaks? How to Cross the leak? How and from where to advance the sheath? Which devices?

26 3 ways to cross

27 Mitral Valve: How to Cross? 1) Anterograde from left atrium - Right Judkins or left Judkins - Terumo wire - TEE guidance!!

28 Steerable sheats St. Jude Lifetech Agilis NxT With guiding catheter + diagnostic catheter inside Hydrophylic wire

29 Mitral Valve: How to Cross? 2) Retrograde via the aorta - Right Judkins or EBU - Terumo wire

30 Mitral Valve: How to Cross? 3) Transapical

31 4 ways to introduce the sheath and the device

32 Mitral Valve: How to Close? Access way for the device 1) Retrograde via the aorta

33 Mitral Valve: How to Close? Access way for the device 2) Anterograde from left atrium a) From IVC

34 Mitral Valve: How to Close? Access way for the device 2) Anterograde from left atrium b) From SVC

35 Mitral Valve: How to Close? 3) Transapical

36 Para mitral valve leak 65 yrs 3 prior mitral valve replacements Severe hemolysis Heart failure, NYHA III

37 Para mitral valve leak

38 Para mitral valve leak Amplatzer PDA occluder

39 Para mitral valve leak Amplatzer PDA occluder

40 Para mitral valve leak

41 It may be better to cross from one side and to introduce the device fom the other side Arteriovenous Loop

42 Mitral Paravalvular Leak Crossing retrograde device anterograde Retrograde crossing Snare

43 Mitral Paravalvular Leak Crossing retrograde device anterograde Arteriovenous loop Sheath in the aorta

44 Mitral Paravalvular Leak Crossing retrograde device anterograde Device in the sheath Device deployment

45 Mitral Paravalvular Leak Crossing retrograde device anterograde Stability test Release

46 Mitral Paravalvular Leak Crossing retrograde device anterograde

47

48 A very special case

49 History 59 yrs, female 1997: Mitral valve replacement - Complicated by myocardial rupture posterior LV wall - Patch repair of the myocardial rupture and 2nd valve replacement (valve was implanted into the patch) 1998: Replacement of the mitral valve due to paravalvular leak. During this operation the orifice of the left atrial appendage (LAA) was closed with a patch

50 History 2003: - leak between LV and LAA - LAA has re-opened - Severe heart failure - Severe hemolysis

51 2004 Catheter in LAA What to do now?

52 2004: Closure of the LAA Closure of the connection between LAA and LA with an ASD occluder

53 2004: Closure of the LAA Closure of the connection between LAA and LA with an ASD occluder

54 1 year later Heart failure improved Hemolysis worse What to do now?

55 2006 Catheter in LV, LAO projection

56 2006: Closure of LV-LAA connection Catheter in LV, RAO projection

57 2006: Closure of LV-LAA connection

58 2006: Closure of LV-LAA connection

59 2008: Myocardial tunnel between LV and LAA: Residual shunt from LV LAA LA through the occluders No improvement of hemolysis What to do now?

60 Amplatzer Vascular Plug Amplatzer Vascular Plug (AVP) AVP Diameter: 4-16 mm Length: 7-8 mm Compatible sheath: 5-8 Fr Amplatzer Vascular Plug II (AVP-II) AVP-II Diameter: 3-22 mm Length: 6-18 mm Compatible sheath: 5-8 Fr Occludes twice faster than AVP

61 2008: Closure of the LV LAA tunnel

62 2008: Closure of the LV LAA tunnel

63 2008: Closure of the LV LAA tunnel

64 Outcome FU 3 yrs Clinically markedly improved - Heart failure improved - Hemolysis

65 Thank you!

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