Trans-catheter Aortic Trans-catheter Aortic Valve ImplantationValve Implantation

Should we all be doing this?Should we all be doing this?

Dr Philip MacCarthy BSc PhD FRCPDr Philip MacCarthy BSc PhD FRCP

Consultant CardiologistConsultant Cardiologist

King’s College Hospital, London, King’s College Hospital, London, UK.UK.

BCIS Autumn Meeting, Crewe Hall, Crewe, September 26th 2008

Otto et al N Engl J Med 1999;341:142–7

Is there an unmet need?Is there an unmet need?

(SCTS 5(SCTS 5thth Blue Book Blue Book 2002003)3)

AVR has become more AVR has become more common in the elderlycommon in the elderly

Is there an unmet need?Is there an unmet need?

What do we currently What do we currently have to offer?have to offer?

Trans-catheter aortic valve Trans-catheter aortic valve implantationimplantation

CoreValve ‘Revalving’ systemCoreValve ‘Revalving’ system – – trans-femoraltrans-femoral

Edwards Sapien™ prosthesisEdwards Sapien™ prosthesis Trans-femoral (using the ‘RetroFlex’ Trans-femoral (using the ‘RetroFlex’

catheter)catheter) Trans-apical (using the ‘Ascendra’ Trans-apical (using the ‘Ascendra’

catheter)catheter)

CoreValve ‘ ReValving’ CoreValve ‘ ReValving’ SystemSystem

Edwards Sapien™ Edwards Sapien™ Trancatheter Heart Valve Trancatheter Heart Valve

prosthesisprosthesis

What are the challenges What are the challenges of setting up a TAVI of setting up a TAVI

programme in the real programme in the real world?world?

King’s College Hospital King’s College Hospital ExperienceExperience

35 patients treated with the 35 patients treated with the Edwards deviceEdwards device 17 Trans-femoral17 Trans-femoral 18 Trans-apical18 Trans-apical

First 17 of these as part of the First 17 of these as part of the PARTNER-EU study, PARTNER-EU study,

Next 18 in the SOURCE registryNext 18 in the SOURCE registry

King’s College Hospital King’s College Hospital ExperienceExperience

20 women (57%)20 women (57%) Mean age - 83.9yrsMean age - 83.9yrs Mean Log Euroscore - 20.3 Mean Log Euroscore - 20.3

(porcelain aorta)(porcelain aorta) Mean peak AV gradient - 85.8mmHgMean peak AV gradient - 85.8mmHg Mean AVA - 0.61cmMean AVA - 0.61cm22

Median LOS - 8 daysMedian LOS - 8 days In-hospital mortality - 2 (5.7%)In-hospital mortality - 2 (5.7%)

Patient work-upPatient work-up Lung/renal function testsLung/renal function tests Carotid DopplersCarotid Dopplers CT aorta – without contrastCT aorta – without contrast Trans-thoracic echoTrans-thoracic echo

Morphology of AV – peak/mean grad + Morphology of AV – peak/mean grad + AVAAVA

Dimensions of AV annulusDimensions of AV annulus Morphology of septumMorphology of septum Presence/mechanism of MRPresence/mechanism of MR LV systolic functionLV systolic function PAP if possiblePAP if possible

TOE – if annulus 24mm or greaterTOE – if annulus 24mm or greater

Patient work-upPatient work-up

Cardiac CatheterisationCardiac Catheterisation Coronary angiogramCoronary angiogram RH cath with PAPRH cath with PAP Aortogram (PA or LAO) – 30ml @ Aortogram (PA or LAO) – 30ml @

15ml/sec15ml/sec Iliofemoral angiogram – 30ml @ Iliofemoral angiogram – 30ml @

6ml/sec6ml/sec No angioseal!No angioseal!

The TeamThe Team

Dedicated Anaesthetist(s)Dedicated Anaesthetist(s) EchocardiologistEchocardiologist PerfusionistPerfusionist Surgical scrub nurseSurgical scrub nurse Cath lab scrub nurseCath lab scrub nurse Surgeon(s)Surgeon(s) Interventional Cardiologist(s)Interventional Cardiologist(s) The Company (for valve crimping)The Company (for valve crimping)

Fluoro

Cardio

CT Surg

Cath lab kit

Valve crimping

Surgicalkit

Echo Machine

Echo

CP bypass

Anaes. Machine

Anaes

Nurse

Screens

Nurse

Rad

Tech

ODA

Rep

The Learning CurveThe Learning Curve

Trans-femoral pAVRTrans-femoral pAVR

TF Valve deploymentTF Valve deployment

Trans-apical pAVRTrans-apical pAVR

A higher risk patient A higher risk patient groupgroup

TA valve deploymentTA valve deployment

The importance of peri-The importance of peri-procedural imagingprocedural imaging

Stenosed native aortic Stenosed native aortic valvevalve

Guidewire across native Guidewire across native AVAV

Valve deploymentValve deployment

Edwards Sapien valve in-Edwards Sapien valve in-situsitu

Potential peri-procedural Potential peri-procedural complicationscomplications

Vascular accessVascular access Passage of introducer sheath Passage of introducer sheath Surgical repair Surgical repair Iliac dissection/rupture Iliac dissection/rupture

Balloon valvuloplastyBalloon valvuloplasty Aortic regurgitationAortic regurgitation CHB on background of RBBBCHB on background of RBBB

Valve deploymentValve deployment Occlusion of coronary ostiaOcclusion of coronary ostia Displacement of prosthesisDisplacement of prosthesis

Rapid pacingRapid pacing OtherOther – –

Interference with the mitral valveInterference with the mitral valve CVACVA

Failed femoral accessFailed femoral access

Iliac balloon occlusionIliac balloon occlusion

Occlusive iliac dissectionOcclusive iliac dissection

Iliac artery rupture…Iliac artery rupture…

……repaired with a covered repaired with a covered stentstent

The importance of case The importance of case selectionselection

Patients with advanced pulmonary Patients with advanced pulmonary disease may do better with a TF disease may do better with a TF approachapproach

Poor LV systolic function - less room Poor LV systolic function - less room for errorfor error

The aetiology of depressed LV The aetiology of depressed LV function and MRfunction and MR

Beware RBBBBeware RBBB

So should we all be doing So should we all be doing it?it?

Some words of cautionSome words of caution The precise need is The precise need is

unknownunknown

There is currently no long-There is currently no long-term dataterm data

Funding issues remain a Funding issues remain a problemproblem

So should we all be doing So should we all be doing it?it?

At the moment NOAt the moment NO - because: - because: Experience should be concentrated in major Experience should be concentrated in major

centrescentres New centres should be closely proctoredNew centres should be closely proctored Centre must have:-Centre must have:-

Experienced cardiac anaesthetistsExperienced cardiac anaesthetists Cardiopulmonary bypass facilityCardiopulmonary bypass facility Excellent imaging abilityExcellent imaging ability Dedicated cardiac ITU/recovery areaDedicated cardiac ITU/recovery area

Long-term data/a solution to funding is Long-term data/a solution to funding is neededneeded

AcknowledgementsAcknowledgements King’s TAVI TeamKing’s TAVI Team:-:-

CT SurgeonsCT Surgeons - Olaf Wendler & - Olaf Wendler & Ahmed El-GamelAhmed El-Gamel

CardiologistsCardiologists – Phil MacCarthy & – Phil MacCarthy & Martyn ThomasMartyn Thomas

EchocardiologistEchocardiologist – Mark – Mark MonaghanMonaghan

AnaesthetistsAnaesthetists – Emma Alcock & – Emma Alcock & Kailasam RajagopalKailasam Rajagopal

Research Sister/Co-ordinatorResearch Sister/Co-ordinator – – Karen Wilson/Beth BrickhamKaren Wilson/Beth Brickham

Other cath lab/theatre staff Other cath lab/theatre staff involvedinvolved