Step-by-step Approach to Paravalvular Leak Closure



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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

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

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

Devices Amplatzer VSD Occluder PDA Occluder

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

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

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

AMPLATZER Vascular Plug 4 0.038 Diagnostic Catheter Floppy Delivery Wire Tip Short Landing Zone

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

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?

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

Aortogram with image intensifyer adjusted according to TEE images

How to Close? Cross the leak with - 5F diagnostic cath - 0.035" hydrophilic wire Long sheath - 6-8 F - Hydrophilic Orthogonal view of the valve Check the motion of the valve leaflets Device implantation Check valve leaflet motion again before device release

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

Case 2 Paravalvular leak at 9 o'clock

Case 2 Crossing with right coronary Judkins catheter

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

Case 2 No relevant residual leak

Case 3 72 y old male patient Dilated CMP (EF 20%) Aortic valve replacement 1994 2 paravalvular leaks (first diagnosed in 1995) Recurrent cardiac decompensation

Case 3 TEE: Paravalvular leaks in SAX and LAX views

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

Case 3 Check with contrast injection Release of occluder

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

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

3 ways to cross

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

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

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

Mitral Valve: How to Cross? 3) Transapical

4 ways to introduce the sheath and the device

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

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

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

Mitral Valve: How to Close? 3) Transapical

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

Para mitral valve leak

Para mitral valve leak Amplatzer PDA occluder

Para mitral valve leak Amplatzer PDA occluder

Para mitral valve leak

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

Mitral Paravalvular Leak Crossing retrograde device anterograde Retrograde crossing Snare

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

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

Mitral Paravalvular Leak Crossing retrograde device anterograde Stability test Release

Mitral Paravalvular Leak Crossing retrograde device anterograde

A very special case

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

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

2004 Catheter in LAA What to do now?

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

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

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

2006 Catheter in LV, LAO projection

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

2006: Closure of LV-LAA connection

2006: Closure of LV-LAA connection

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

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

2008: Closure of the LV LAA tunnel

2008: Closure of the LV LAA tunnel

2008: Closure of the LV LAA tunnel

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

Thank you!