1 medtronic corevalve ® transcatheter aortic valve implant summary of clinical experience july 2010...

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Valvular Heart DiseaseValvular Heart Disease

2012: The Year of the Valve2012: The Year of the Valve

Robert H. McQueen, MD, FACCRobert H. McQueen, MD, FACC

Mountain States Medical Group – CardiologyMountain States Medical Group – Cardiology

January 27, 2012January 27, 2012

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• Structural abnormalities and disorders of cardiac Structural abnormalities and disorders of cardiac valve function result in valvular heart diseasevalve function result in valvular heart disease

• Disruption in the anatomic integrity of cardiac valves Disruption in the anatomic integrity of cardiac valves may result in disorders of the valve surface, valvular may result in disorders of the valve surface, valvular stenosis, valvular regurgitation, or mixed disease stenosis, valvular regurgitation, or mixed disease with stenosis and regurgitation.with stenosis and regurgitation.

• Clinical understanding and experience of valvular Clinical understanding and experience of valvular heart disease has changed dramatically in the past 5 heart disease has changed dramatically in the past 5 decades, due to a number of factors: decades, due to a number of factors: – Recognition of nonrheumatic causesRecognition of nonrheumatic causes– Reduction in incidence of rheumatic feverReduction in incidence of rheumatic fever– Increased life expectancyIncreased life expectancy– Development of new technology for Dx and TxDevelopment of new technology for Dx and Tx

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• Although there has been a dramatic reduction in Although there has been a dramatic reduction in rheumatic valve disease in industrialized countries rheumatic valve disease in industrialized countries over the past 50 years, there has not been a similar over the past 50 years, there has not been a similar reduction in valve surgery.reduction in valve surgery.

• Calcific aortic stenosis and mitral annular Calcific aortic stenosis and mitral annular calcification are common valvular abnormalities in calcification are common valvular abnormalities in the elderly, and their incidence has increased due to the elderly, and their incidence has increased due to an increase in life expectancy.an increase in life expectancy.

• Valvular heart disease still constitutes a major health Valvular heart disease still constitutes a major health problem even in industrialized countries, and will problem even in industrialized countries, and will continue to do so with aging populations.continue to do so with aging populations.

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Valvular DiseaseValvular Disease

• Although the incidence of degenerative disease Although the incidence of degenerative disease increases with age, aging itself does not appear to be increases with age, aging itself does not appear to be the only factor.the only factor.

• The initial lesion of calcified aortic valve disease The initial lesion of calcified aortic valve disease seems to involve an active process similar to that of seems to involve an active process similar to that of atherosclerosis, including lipid deposition, atherosclerosis, including lipid deposition, macrophage infiltration, and production of other macrophage infiltration, and production of other proteins which negatively affect the valvular proteins which negatively affect the valvular structurestructure

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Aortic StenosisAortic Stenosis• Over 300,000 patients have severe AS worldwideOver 300,000 patients have severe AS worldwide

• Most commonly caused by age-related progressive Most commonly caused by age-related progressive calcification (> 50% of cases) usually occurs later, calcification (> 50% of cases) usually occurs later, 70-80 yr of age. Some degree of calcification found 70-80 yr of age. Some degree of calcification found in 75% of people > 85.in 75% of people > 85.

• Congenital Bicuspid AS (30-40%) usually occurs Congenital Bicuspid AS (30-40%) usually occurs earlier, 40–50 yr of age. 1-1.5% of population have earlier, 40–50 yr of age. 1-1.5% of population have bicuspid aortic valvesbicuspid aortic valves

• Acute rheumatic fever (<10%)Acute rheumatic fever (<10%)

• HTN, DM, Elevated Lipoproteins, and Uremia may HTN, DM, Elevated Lipoproteins, and Uremia may encourage/accelerate processencourage/accelerate process

• Severe AS found in 2% over age 65, 3% over 75, and Severe AS found in 2% over age 65, 3% over 75, and 4% over 854% over 85

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Severe AS Patients Not Undergoing AVR Have Severe AS Patients Not Undergoing AVR Have a Shorter Life Expectancy Than Those a Shorter Life Expectancy Than Those Receiving AVRReceiving AVR

1. Varadarajan P, Kapoor N, Bansal RC, Pai RG. Survival in elderly patients with severe aortic stenosis is dramatically improved by aorticvalve replacement: results from a cohort of 277 patients aged ≥ 80 years. Euro J Cardiothorac Surg. 2006;30:722-727.

1yr87%

2yr40%

5yr22%

1yr52%

2yr78%

5yr68%

1

0.8

0.6

0.4

0.2

0

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mu

lati

ve S

urv

ival

0 2 4 6 8 10 12

Time in Years

P < 0.0001

AVR n = 80

No AVR n = 197

Number at risk

Survival of patients with severe AS with and without AVR

80 54 33 16 4 263 41 26 8 3 AVR group197 67 37 17 6 197 48 29 9 4 No AVR group

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Aortic Stenosis SymptomsAortic Stenosis Symptoms

• Degree dependentDegree dependent

• Mild/Mod – Few if any symptomsMild/Mod – Few if any symptoms

• Severe – Syncope, CHF, and AnginaSevere – Syncope, CHF, and Angina

• Most often AS presents with SOB/DOEMost often AS presents with SOB/DOE

• As gradient increases, concentric hypertrophy As gradient increases, concentric hypertrophy develops as a result of excessive pressure loadingdevelops as a result of excessive pressure loading

• Later progresses to LV dilation/thinning with ultimate Later progresses to LV dilation/thinning with ultimate function deterioration and increased filling pressuresfunction deterioration and increased filling pressures

• CHF and AS = 2 year mortality of 50%CHF and AS = 2 year mortality of 50%

• Syncope (usually exertional) = 3 yr mortality of 50%Syncope (usually exertional) = 3 yr mortality of 50%

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Aortic StenosisAortic Stenosis

• Angina occurs as LVH progresses and inability to Angina occurs as LVH progresses and inability to supply thickened myocardium with adequate supply thickened myocardium with adequate oxygenation.oxygenation.

• Angina = 50% 5 yr mortalityAngina = 50% 5 yr mortality

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Aortic Stenosis - DiagnosisAortic Stenosis - Diagnosis

• Adequate H & PAdequate H & P

• EKG = LVH with possible strain/ischemia if advancedEKG = LVH with possible strain/ischemia if advanced

• CXR = Calcification of Aortic valve with possible CXR = Calcification of Aortic valve with possible Cardiac enlargement secondary to LVHCardiac enlargement secondary to LVH

• Echo (TTE or TEE) best non-invasive imaging Echo (TTE or TEE) best non-invasive imaging modality, 3D may provide additional informationmodality, 3D may provide additional information

• Cardiac Cath (R/L/LV/Root) remains gold standard Cardiac Cath (R/L/LV/Root) remains gold standard for exact gradient measurement and coronary for exact gradient measurement and coronary angiogramangiogram

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Aortic Stenosis – Medical TreatmentAortic Stenosis – Medical Treatment• In general, all medical therapies have poor effect on In general, all medical therapies have poor effect on

AS, important to treat associated symptomsAS, important to treat associated symptoms– Angina = B-Blocker or Ca blockerAngina = B-Blocker or Ca blocker– Avoid peripheral vasodilators, unable to increase Avoid peripheral vasodilators, unable to increase

C.O. to compensateC.O. to compensate– (NTG, ACE/ARB, Alpha blockers, Hydralazine)(NTG, ACE/ARB, Alpha blockers, Hydralazine)

If no significant symptoms:If no significant symptoms:

Mild/Mod stenosis = Echo every 1-2 yr, +/- GXTMild/Mod stenosis = Echo every 1-2 yr, +/- GXTMod/Severe = Echo every 3-6 months, ? StressMod/Severe = Echo every 3-6 months, ? Stress

Valve replacement if symptoms, Echo changes Valve replacement if symptoms, Echo changes

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Aortic Stenosis – Invasive optionsAortic Stenosis – Invasive options

• Balloon Valvuloplasty generally ineffective long-term Balloon Valvuloplasty generally ineffective long-term and used only for palliative treatment or as bridge to and used only for palliative treatment or as bridge to subsequent proceduresubsequent procedure

• Surgical valve replacement remains the Gold Surgical valve replacement remains the Gold Standard for alleviation of symptoms and improved Standard for alleviation of symptoms and improved survivalsurvival

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Aortic RegurgitationAortic Regurgitation

• Half of all cases due to aortic root dilation which is Half of all cases due to aortic root dilation which is usually idiopathic (> 80%) but may be secondary to usually idiopathic (> 80%) but may be secondary to aging, syphilitic aortitis, osteogenesis imperfecta, or aging, syphilitic aortitis, osteogenesis imperfecta, or dissectiondissection

• 15% of cases secondary to bicuspid AV15% of cases secondary to bicuspid AV

• 15% of cases secondary to rheumatic fever15% of cases secondary to rheumatic fever

• May accompany AS with post-stenotic dilation of AO May accompany AS with post-stenotic dilation of AO root and subsequent associated regurgitationroot and subsequent associated regurgitation

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Aortic RegurgitationAortic Regurgitation

• Acute: Sudden increase in LV volume, less efficient Acute: Sudden increase in LV volume, less efficient contraction (shifting Frank-Starling curve), increased contraction (shifting Frank-Starling curve), increased end-diastolic pressures resulting in pulmonary end-diastolic pressures resulting in pulmonary edemaedema

• Severe = life-threatening emergency associated with Severe = life-threatening emergency associated with high mortality if AVR not performedhigh mortality if AVR not performed

• Chronic: LV hypertrophy and volume overload is Chronic: LV hypertrophy and volume overload is compensated for over timecompensated for over time

• Eventual LV decompensation and filling pressures Eventual LV decompensation and filling pressures escalate = SOB/CHF (PND, DOE)escalate = SOB/CHF (PND, DOE)

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Aortic Regurgitation – Diagnostic ToolsAortic Regurgitation – Diagnostic Tools


• EKG may suggest LVH if chronicEKG may suggest LVH if chronic

• CXR may show AV calcification with possible cardiac CXR may show AV calcification with possible cardiac enlargement +/- widened mediastinumenlargement +/- widened mediastinum

• Echo (TTE/TEE) remains best non-invasive toolEcho (TTE/TEE) remains best non-invasive tool

• Cardiac Cath with Root, Gold StandardCardiac Cath with Root, Gold Standard

• CT may be helpful to R/O Dissection CT may be helpful to R/O Dissection

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Aortic Regurgitation - TreatmentAortic Regurgitation - Treatment

• Vasodilators preferred (ACE/ARB, Hydralazine) but Vasodilators preferred (ACE/ARB, Hydralazine) but only if HTN present, for afterload reductiononly if HTN present, for afterload reduction

• AVR indicated if:AVR indicated if:– Any symptoms suggestive of CHFAny symptoms suggestive of CHF– Fall in EF < 50% regardless of sxsFall in EF < 50% regardless of sxs– Severe LV dilation or abnormal GXTSevere LV dilation or abnormal GXT

If stable without above findings:If stable without above findings:Mild/Mod AI: Echo every 1-2 yr +/- GXTMild/Mod AI: Echo every 1-2 yr +/- GXTMod/Severe AI: Echo every 3-6 mosMod/Severe AI: Echo every 3-6 mos

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Mitral StenosisMitral Stenosis

• Almost all cases are secondary to rheumatic feverAlmost all cases are secondary to rheumatic fever

• Normally latent period @ 16 yrs. Once symptoms Normally latent period @ 16 yrs. Once symptoms develop, progression to stenosis @ 9 years.develop, progression to stenosis @ 9 years.

• Little role of medical therapy other than symptomatic Little role of medical therapy other than symptomatic supportsupport

• Patients with severe MS who refuse MV Patients with severe MS who refuse MV replacement/repair, 44% survival @ 5 yr, 32% @ 10yr. replacement/repair, 44% survival @ 5 yr, 32% @ 10yr.

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Mitral StenosisMitral Stenosis

• LA/LV gradient increases with increased HR or LA/LV gradient increases with increased HR or Cardiac outputCardiac output

• As LA/LV gradient increases, the amount of time to As LA/LV gradient increases, the amount of time to fill the LV increases, now relying on the “atrial kick”fill the LV increases, now relying on the “atrial kick”

• Ultimately diastolic filling is insufficient resulting in Ultimately diastolic filling is insufficient resulting in decreased C.O. and elevated LA pressures = decreased C.O. and elevated LA pressures = pulmonary edemapulmonary edema

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Mitral Stenosis - DiagnosisMitral Stenosis - Diagnosis


• EKG = P mitralie (Broad notched P), possible AFEKG = P mitralie (Broad notched P), possible AF

• CXR = LAE, pulm edemaCXR = LAE, pulm edema

• Echo = Best non-invasive test (TEE > TTE)Echo = Best non-invasive test (TEE > TTE)

• Cath (R/L with simultaneous LV/Wedge) – Gold Cath (R/L with simultaneous LV/Wedge) – Gold StandardStandard

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Mitral Stensis – Treatment OptionsMitral Stensis – Treatment Options

• If no symptoms, Echocardiographic monitoringIf no symptoms, Echocardiographic monitoring

• If Symptoms:If Symptoms:– Mitral valve replacement/repairMitral valve replacement/repair– Mitral Valvuloplasty:Mitral Valvuloplasty:

• Leaflet mobilityLeaflet mobility• Leaflet thickeningLeaflet thickening• Subvalvular thickeningSubvalvular thickening• Amount of calcification presentAmount of calcification present

Class III or IV onlyClass III or IV onlyIf score > 8, surgery preferred If score > 8, surgery preferred

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Mitral ValvuloplastyMitral Valvuloplasty• Performed via femoral veinPerformed via femoral vein

• Requires trans-septal punctureRequires trans-septal puncture

• Three stagged balloonThree stagged balloon– 11stst: Inflated in LV and pulled back against MV leaflets: Inflated in LV and pulled back against MV leaflets– 22ndnd: Inflated in LA to secure leaflets in center: Inflated in LA to secure leaflets in center– 33rdrd: Center inflated to “crack” leaflets: Center inflated to “crack” leafletsUsually all performed in < 30 secUsually all performed in < 30 sec

Most serious complication is severe MR (torn leaflet or Most serious complication is severe MR (torn leaflet or subvalvular apparatus) requiring surgical repairsubvalvular apparatus) requiring surgical repair

Requires vigilant F/U for restenosis: Requires vigilant F/U for restenosis: 70-75% free of restenosis @ 10 yr70-75% free of restenosis @ 10 yr40% free of restenosis @ 15 yr40% free of restenosis @ 15 yr

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Mitral RegurgitationMitral Regurgitation

• Most common form of valvular heart diseaseMost common form of valvular heart disease

• Problem with either papillary muscle or chordae Problem with either papillary muscle or chordae tendineae can produce sub-valvular MR tendineae can produce sub-valvular MR

• Most common cause is papillary muscle fibrosis Most common cause is papillary muscle fibrosis (ischemic papillary muscle damage) after MI with (ischemic papillary muscle damage) after MI with either shortening or lengthening and possible LV either shortening or lengthening and possible LV dilation dilation

• 50% of all infarcts have some involvement of the 50% of all infarcts have some involvement of the papillary musclespapillary muscles

• Myxomatous degeneration most common form of Myxomatous degeneration most common form of valvular regurgitation valvular regurgitation

• All result in failure in coaptation All result in failure in coaptation

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Mitral Regurgitation - DiagnosisMitral Regurgitation - Diagnosis


• EKG = LAE, LVH, ? AFEKG = LAE, LVH, ? AF

• Echo (TEE/TTE) best diagnostic toolEcho (TEE/TTE) best diagnostic tool

• Cardiac cath best invasiveCardiac cath best invasive

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Mitral Regurgitation – Treatment OptionsMitral Regurgitation – Treatment Options

• Medical treatment consist of After-load reduction Medical treatment consist of After-load reduction (ACE/Hydralazine)(ACE/Hydralazine)

• Acute management may require IABP, IV Nipride and Acute management may require IABP, IV Nipride and surgical repair of Valvesurgical repair of Valve

• Mitral Replacement or Repair +/- ringMitral Replacement or Repair +/- ring

• Replace when symptoms present, LV dysfunction Replace when symptoms present, LV dysfunction (EF<50), or LVESD > 45(EF<50), or LVESD > 45

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NewNew Percutaneous Valvular Percutaneous Valvular Therapies Therapies

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Aortic Stenosis - Percutaneous Aortic Stenosis - Percutaneous TherapiesTherapies

• Surgical Aortic valve replacement is not performed in Surgical Aortic valve replacement is not performed in up to 1/3 of eligible pts due to advanced age, co-up to 1/3 of eligible pts due to advanced age, co-morbidities, previous cardiac surgery, low EF, morbidities, previous cardiac surgery, low EF, Concomitant CAD and patient refusal Concomitant CAD and patient refusal

• Percutaneous treatment of CAD is now the treatment Percutaneous treatment of CAD is now the treatment of choice for most individuals, however, the of choice for most individuals, however, the treatment of structural heart disease via a treatment of structural heart disease via a percutaneous approach has been slower to evolvepercutaneous approach has been slower to evolve

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• Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) allows a less invasive means of valve replacement allows a less invasive means of valve replacement via a transfemoral, transapical, or subclavian via a transfemoral, transapical, or subclavian approach with favorable results in terms of approach with favorable results in terms of procedural success, hemodynamic performance, procedural success, hemodynamic performance, peri-procedural complications, and survivalperi-procedural complications, and survival

• Currently in US, only Pulmonic valves are approved Currently in US, only Pulmonic valves are approved (Melody – Medtronic)(Melody – Medtronic)

• Outside US, 2 current platforms in use, Edwards Outside US, 2 current platforms in use, Edwards Sapian Valve and Medtronic Corevalve. Sapian Valve and Medtronic Corevalve.

• Over 15,000 percutaneous valves implanted Over 15,000 percutaneous valves implanted worldwide since 2002worldwide since 2002

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Edwards Sapian ValveEdwards Sapian Valve• 3 bovine pericardial leaflets hand-sewn to a stainless 3 bovine pericardial leaflets hand-sewn to a stainless

steel balloon expandable stent with fabric covering steel balloon expandable stent with fabric covering of the lower portion of the stent to facilitate of the lower portion of the stent to facilitate formation of a sealformation of a seal

• Valve leaflets undergo anticalcification treatment Valve leaflets undergo anticalcification treatment during production in an attempt to maximize during production in an attempt to maximize longevitylongevity

• Currently produce in 3 sizes: 23,26, and 29 mmCurrently produce in 3 sizes: 23,26, and 29 mm

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Transcatheter ValvesTranscatheter Valves

Three Primary Components: Three Primary Components:

1.1. Tissue Valve Tissue Valve

2.2. Supporting FrameSupporting Frame

3.3. Delivery SystemDelivery System

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Medtronic CoreValve Revalving SystemMedtronic CoreValve Revalving System

• Self-expanding nitinol stent (no balloon delivery)Self-expanding nitinol stent (no balloon delivery)

• Delivered through a 18Fr systemDelivered through a 18Fr system

• 2 Current sizes: 26 & 29mm2 Current sizes: 26 & 29mm

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CoreValve ExperienceCoreValve Experience

More than 10,000 implants in 34 countriesMore than 10,000 implants in 34 countries

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DesignDesign

• Transfemoral approach for beating-heart, transcatheter aortic valve implantation (TAVI)Transfemoral approach for beating-heart, transcatheter aortic valve implantation (TAVI)

Components:Components:

• 18Fr catheter delivery system 18Fr catheter delivery system

• Self-expanding multi-level Nitinol frame Self-expanding multi-level Nitinol frame

• Porcine pericardial tissue valvePorcine pericardial tissue valve

Design & System ComponentsDesign & System Components

Over-the-wire 0.035 compatible

Caution: The CoreValve® System is not currently available in the USA for clinical trials or for sale. CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.

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Valve Design FeaturesValve Design Features

Orientation Crowns

Sealing Skirt• Porcine pericardium• Intra-annular sealing

Nitinol Frame• Self-expanding frame• Radiopaque design • Memory shaping properties

Pericardial Porcine Tissue Valve• Supra-annular valve function• Tall commissures

Multi-Level Radial Forces• Outflow Aspect• Hoop Strength• Inflow Aspect

Delivery Fixation Hoops


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Position and FixationPosition and Fixation


Inflow

Outflow

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TAVI InclusionTAVI Inclusion• Severe symptomatic AS with Aortic valve area less Severe symptomatic AS with Aortic valve area less

than 1 cm2 or mean gradient > 40mmHg, advanced than 1 cm2 or mean gradient > 40mmHg, advanced age > 80age > 80

• If age < 80 then one of the following: Liver cirrhosis, If age < 80 then one of the following: Liver cirrhosis, Significant pulmonary HTN, previous cardiac Significant pulmonary HTN, previous cardiac surgery, porcelain aorta, severe COPD, recent PEsurgery, porcelain aorta, severe COPD, recent PE

• Aortic annulus sized by TEE or CT to avoid size Aortic annulus sized by TEE or CT to avoid size mismatchmismatch

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TAVI ExclusionTAVI Exclusion

• Bulky aortic calcificationBulky aortic calcification

• ? Bicuspid aortic valve? Bicuspid aortic valve

• Short Distance (< 8mm) between the aortic annulus Short Distance (< 8mm) between the aortic annulus and the Left main coronaryand the Left main coronary

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TAVI ResultsTAVI Results• 20% reduction in mortality with significant 20% reduction in mortality with significant

improvement in Valve gradients, quality of life, improvement in Valve gradients, quality of life, reduced hospitalizations compared with Med Rxreduced hospitalizations compared with Med Rx

• Most common hospital complications were bleeding Most common hospital complications were bleeding (31%), CIN (18%), Vascular (16%), CVA (11%), (31%), CIN (18%), Vascular (16%), CVA (11%), Coronary occlusion, Persistent AV blockCoronary occlusion, Persistent AV block

• Most common long-term complication is Peri-Most common long-term complication is Peri-valvular leak, @ 75% mild and well tolerated, @ 20% valvular leak, @ 75% mild and well tolerated, @ 20% mod/severe and require either post-dilation, mod/severe and require either post-dilation, placement of second valve, or surgeryplacement of second valve, or surgery

• Causes: Prosthesis mismatch, valve malposition, Causes: Prosthesis mismatch, valve malposition, under expansion of stent, valve damage, operator under expansion of stent, valve damage, operator experienceexperience

• MSCT to evaluate annulus to Coronary distanceMSCT to evaluate annulus to Coronary distance

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TAVI ResultsTAVI Results• 1 year mortality after TAVI = 10% (Pt age, disease 1 year mortality after TAVI = 10% (Pt age, disease

states)states)

• MACE @ 30% MACE @ 30%

• Stroke after Surgical AVR Stroke after Surgical AVR – 1.5% but increases to 2-4% in high-risk pts1.5% but increases to 2-4% in high-risk pts– 1.5 – 6% at 1yr1.5 – 6% at 1yr

At 1 year, TAVI and SAVR showed similar rates of At 1 year, TAVI and SAVR showed similar rates of survival, although there were important survival, although there were important differences in periprocedural risksdifferences in periprocedural risks

? Long-term valve durability? Long-term valve durabilityNewer Generation Devices – fewer complicationsNewer Generation Devices – fewer complications

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TAVI PlacementTAVI Placement

High deployment:High deployment:– Device embolizationDevice embolization– Coronary ischemia owing to compromise of one Coronary ischemia owing to compromise of one

or both coronary ostiaor both coronary ostia– Aortic injuryAortic injury

Low Deployment:Low Deployment: - Impingement upon the AV node causing - Impingement upon the AV node causing

bradycardia or BBB or MV apparatus resulting in bradycardia or BBB or MV apparatus resulting in acute and ofter poorly tolerated MRacute and ofter poorly tolerated MR

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TAVI SummaryTAVI Summary

• Team approach mandatory Team approach mandatory

• Extensive pre-procedure planning/imagingExtensive pre-procedure planning/imaging

• Family discussionsFamily discussions

• Intra-Cardiac Echo/TEE neededIntra-Cardiac Echo/TEE needed

• Emergency back-up procedures in placeEmergency back-up procedures in place

• No substitute for experienceNo substitute for experience

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? Mitral Valve Replacement? Mitral Valve Replacement• Percutaneous replacement of MV not currently Percutaneous replacement of MV not currently

possible due to anatomic features of the MV that possible due to anatomic features of the MV that make fixation and peri-valvular seal desires a make fixation and peri-valvular seal desires a challengechallenge

• Calcified aortic valve OK for TAVI, other locations Calcified aortic valve OK for TAVI, other locations require prosthetic material to provide support for require prosthetic material to provide support for Transcatheter stent-mounted valvesTranscatheter stent-mounted valves

• Annuloplasty ring in Annulus may provide “landing Annuloplasty ring in Annulus may provide “landing zone” for secure deploymentzone” for secure deployment

• Valve-in-Valve has been done successfully in animal Valve-in-Valve has been done successfully in animal modelsmodels

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Mitral RegurgitationMitral RegurgitationMitraClip – Abbott VascularMitraClip – Abbott Vascular

• Edge-to-edge technique (Alfieri 1991, Double Orifice), Edge-to-edge technique (Alfieri 1991, Double Orifice), Open heart procedure that sutured free edge of Open heart procedure that sutured free edge of leaflets at site of MR which created 2 orificesleaflets at site of MR which created 2 orifices

• Safe, effective, and durableSafe, effective, and durable

• Historically Open procedure - Min. invasive robotic Historically Open procedure - Min. invasive robotic with direct (trans-atrial) off-pump suture based with direct (trans-atrial) off-pump suture based approach – Percutaneous Clipapproach – Percutaneous Clip

• 2003 first in Man2003 first in Man

• Clip currently available in Europe and in trials in US Clip currently available in Europe and in trials in US (Everest II) in high-risk pts with functional MR(Everest II) in high-risk pts with functional MR

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MitraClip – Abbott VascularMitraClip – Abbott Vascular

• 24Fr, trans-septal approach24Fr, trans-septal approach

• Cobalt/chromium clipCobalt/chromium clip

• Capture of MV leaflets at site of MRCapture of MV leaflets at site of MR

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Everest II ResultsEverest II Results

• At 12 months, the rates of primary end point for At 12 months, the rates of primary end point for efficacy were 55% MitraClip vs 73% Surgicalefficacy were 55% MitraClip vs 73% Surgical

• Death: 6% each groupDeath: 6% each group

• Surgery for valve dysfunctin: 20% vs 2%Surgery for valve dysfunctin: 20% vs 2%

• Severe MR: 21% vs 20%Severe MR: 21% vs 20%

• Major adverse events: 15% vs 48% at 30 daysMajor adverse events: 15% vs 48% at 30 days

• At 12 months, both had improved LV size, functional At 12 months, both had improved LV size, functional class, and QOL measuresclass, and QOL measures

Although percutaneous repair was less effective at Although percutaneous repair was less effective at reducing MR, the procedure was associated with reducing MR, the procedure was associated with superior safety and similar improvements in superior safety and similar improvements in outcomesoutcomes

1 medtronic corevalve ® transcatheter aortic valve implant summary of clinical experience july 2010...

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