TAVI procedure review with cases

Transcatheter Aortic Valve Intervention

Cath Conference Abdelkader Almanfi, MD, MRCP-UK04/24/2014 Trans-catheter Aortic Valve Implantation

OverviewIntroductionProcedureIndications & Pre-procedural work up Procedure & Hardware Post-op care, Complications & Management

Clinical cases Conclusions

Introduction AVRHigh risk for surgeryComplications30-40% do not undergo SxAdvanced ageLV dysfunctionMultiple co-morbiditiesPt. preferencePhysician assessmentSymptomatic Severe Aortic Stenosis

Prohibitive riskInoperability ~8% mortality (STS, EuroSCORE)~2% Stroke~11% prolonged ventilationOrgan failureThromboembolic ComplicationsBleedingProsthetic valve Dysfunction

J. Am. Coll. Cardiol. 2012;59;1200-1254

Introduction AlternativesBalloon Aortic ValvuloplastyPalliation Bridge to AVRMedical conservative management poor prognosis TAVI - (TAVI) was developed to address this unmet need, After the demonstration of feasibility of TAVI in 2002. now widely practiced, with >50 000 patients treated worldwide, and the technique has been recommended as an alternative strategy for patients in high-risk surgical groups.

Transcatheter Aortic Valve InterventionIndications & Pre-procedural work up

Indications . Symptomatic severe calcific Aortic Stenosis [trileaflet] who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk as defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease.

TAVR is a reasonable alternative to surgical AVR in patients at high surgical risk (PARTNER Trial Criteria: STS >8)J. Am. Coll. Cardiol. 2012;59;1200-1254

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Indications

Patient selection in clinical trialsLogistic EuroSCORE >20% or STS Score > 10.J. Am. Coll. Cardiol. 2012;59;1200-1254

STS is the Society of Thoracic Surgeons Score.Nithin P G8

Contraindications

Recent MI 1 monthRecent Stroke 6 months Nithin P G9

Requisites Heart team approachSpecific team leaderClose communicationPreplanning procedure

Large cathlabs/ hybrid roomsFluoroscopic imagingTEE capabilitiesGeneral Anesthesia / CPBVascular intervention for vascular complications Urgent AVR, CABG,Hemodynamic monitoring and management

Work upPre-anesthetic work upCardiothoracic evaluation [access, AVR, risk assessment]ImagingAS severity, morphology, calcification, annular size and shapeAortic root, annulus to coronary ostia distance (>8mm), Atheroma burden, calcificationOther valvular disease, sub aortic obstructionLV functionVascular anatomy from access site to annulus

Work up

Role of imaging in pre-procedural and post procedural assessment

J. Am. Coll. Cardiol. 2012;59;1200-1254

MDCT imaging for arterial calcification.

Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087 2008 European Association for Cardio-thoracic Surgery

MDCT imaging for arterial calcification.

MDCT imaging for calculation of the dimension of the aortic annulus.


MDCT imaging for calculation of the dimension of the aortic annulus.

MDCT imaging 3D reconstruction of iliac artery.


MDCT imaging 3D reconstruction of iliac artery.

Transcatheter Aortic Valve InterventionProcedure & Hardware

Procedure & HardwareLA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg / MAP >75 mm Hg]Vascular accessSites Transfemoral. Less invasive, can be done LATransapicalLeft ant. Thoracotomy, more invasiveMore direct, shorter catheter, easy delivery Septal hypertrophyAscendra2, Sapien valveTransaortic Upper partial sternotomyMini-sternotomy 2/3 RICSAorta 5 cm above valveLess painful, familiar approach to surgeonsManipulation of ascending aortaSubclavian

Percutaneous or Cut-down techniqueJ. Am. Coll. Cardiol. 2012;59;1200-1254www.edwards.com

Procedure & HardwarePacing leads Trans venous or epicardialAnticoagulationLarge sheaths Heparin [ACT>250]Intra-procedural TEEGuidewire placementValve placementStable positionNo coronary obstructionNo interference with mitral valve functionNo conduction system impingementNo overhanging native aortic leafletsAvoidance of aortic root complications (rupture & dissection)Post deployment assessment [MR, AR]

TEE- Mid esophageal long axis view

Procedure & Hardware

Balloon Aortic ValvotomyPrepping and draping Anesthesia diagnostic arterial access: C/L FA access with 6F sheath pigtail catheter for C/L iliofemoral angiography, location of puncture markedFemoral vein access: I/L to diagnostic access with 7F sheath, for RHC and pacing leads

BAVValve implantation

MMCTS.2007.003077

Procedure & HardwareTherapeutic arterial access: Percutaneous puncture/surgical preparation standard diagnostic J 0.035 Guidewire +18 or 24F long sheath, heparinValve crossing : AL1 into ascending aorta exchanged with straight tip 0.035 Guidewire to cross AV AL1 into LV & wire exchanged with Amplatz extra stiff 0.035, 260 cm length Guidewire

Balloon aortic valvuloplasty: 20x40 mm balloon Appropriate angiographic projection in line with the plane of annulus [LAO/Cran ] (or you can obtain this angle from CT scan images) midpoint of balloon at the annular level PACE INFLATE CHECK DEFLATE stop pacing

MMCTS.2007.003077


Sapien XT device

CoreValve deviceSelf expandable Nitinol framePorcine Pericardial TissueEuropean Heart Journal (2011) 32, 140147

Cardiol Clin 29 (2011) 211222Superior hemodynamicsLower risk for PPM


CrimperDilator setInflation device www.edwards.com

Valve Preparation Table

Normal salineHeparinized SalinePapaverine & KY GelMineral oil0.035 J WireInflation DeviceEdwards Rep & Interventional Cardiologist

23

Progressive Arterial Dilation

18,20,22,23,25 & 28 French dilators25F Outer Diameter Sheath for 23 mm valve

Valve Prep

Valve Prep & Delivery

Balloon aortic valvuloplasty

Procedure & HardwarePressure tracings before and after TAVI

European Heart Journal (2011) 32, 140147

Procedure & HardwareSapien device Balloon deploymentTransapical deployment alsoLeaflets in open mode, more chance for AR

CoreValve devicePartially repositionableLarger annular sizeHigher chance for CHB

Sapien XT device Lesser calcification [reduction of 98% calcium binding sites]Shorter stent sizeMore radial strength grater durabilityMore closed form, less chance for AR

www.edwards.comwww.medtronic.com

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European Heart Journal (2011) 32, 140147

Device success

Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery systemCorrect position of the device in the proper anatomical locationIntended performance of the prosthetic heart valve (AVA >1.2 cm2 and mean AV gradient < 20 mm Hg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR)Only 1 valve implanted in the proper anatomical locationJ. Am. Coll. Cardiol. 2012;59;1200-1254

Transcatheter Aortic Valve InterventionPost-op care, Complications & Mx

Post-Operative Care & Monitoring Immediate or early extubation, early mobilization

Adequate analgesia, control postoperative hypertension, monitor for any bleed

Monitor vital parameters including fluid balance, renal status, and AV conduction system.

Pre-discharge TTE, DAPTJ. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve.Treated with CPB device explantation AVRAlso PCI/CABGCardiol Clin 29 (2011) 211222J. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management Incidence of CHB requiring permanent pacemaker implantation has been higher with the CoreValve (19.2% to 42.5%) than with the Sapien valve (1.8% to 8.5%) [larger profile and extension low into the LVOTOccurrence of CHB/LBBBBAV 46%Balloon/prosthesis positioning &wire-crossing of the aortic valve 25%Prosthesis expansion 29%. Pre-existing RBBB risk factor for CHB

J. Am. Coll. Cardiol. 2012;59;1200-1254

Case # 1DB is a 87 year old Male with symptomatic severe ASIschemic CMP NYHA 4BSA 1.83 Cr 1.09 Hb 14.5

High Risk due to followingFrailtyCAD (CABG)PCI (2 months ago)ICMP (LVEF 25-30%)CHF (Class IV)CKD with (B/L renal stents)39STS 21.2Euro Score II 39.02Procedure NameIsolated AVReplRisk of Mortality21.276%Morbidity or Mortality55.053%Long Length of Stay35.812%Short Length of Stay4.059%Permanent Stroke3.397%Prolonged Ventilation46.630%DSW Infection0.913%Renal Failure23.626%Reoperation22.903%

Echocardiography TEE performed Required MeasurementsAVA 0.7 cm2Peak Velocity 3.17 m/sAVA index Annulus Diameter 21 mmMean Gradient 25 mmHgEjection Fraction25-30%

Findings aortic valve calcificationSevere ARMild MRMild TRNone

40

40

Echocardiography 22.0 cm

Proposed 26mmSapien

Echocardiography

Echocardiography

CT MIP

Vitrea View of Gated CTA of Aortic Annulus329 mm2

CTA : Small AAAAortic bifurcationProximal common iliacsBilateral common iliac dissectionBilateral renal stents

Distal Aorta

CTA : External iliac arteries

CTA : CFA (Axial Views)

Procedural Plan Annulus Diameter MeasurementTHV Valve SizeProposedFemoral Access SideProposedSmallest Vessel Diameter Measurement TEE24x17 Gated CTA26 mmTA 7 mm

Special Case ConcernsReduced EF 25-30%

Videos for TAVI procedure

Complications & Management

Aortic RegurgitationTypically paravalvular mild or mild-moderate severityMost of AR disappears or reduces at 1 yr follow-up [13% absent, 80% mild AR]J. Am. Coll. Cardiol. 2012;59;1200-1254Cardiol Clin 29 (2011) 211222

Complications & Management Paravalvular AR

Central valvular ARPost-deployment balloon dilation, rapid RV pacing for stabilization, valve in valve implantation

Usually self-limited, Gentle probing of leaflets with a soft wire or catheterDelivery of a 2nd TAVR device, valve in valve

J. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management

Rapid Pacing for stabilization

Valve in Valve ImplantationReduction of diastoleCardiol Clin 29 (2011) 211222

Case # 2BH is 80 years old female with symptomatic severe AS NYHA 3 BMI 42.7 Cr 0.91Hb 13.3 PLT 164

High risk due to followingCAD-CABGDMCOPDMorbid obesity (BMI 42.7)CHF54STS 16.5Euro Score II 9.1Procedure NameIsolated AVReplRisk of Mortality16.524%Morbidity or Mortality46.470%Long Length of Stay34.552%Short Length of Stay5.796%Permanent Stroke3.058%Prolonged Ventilation43.166%DSW Infection1.663%Renal Failure24.814%Reoperation12.086%

Echocardiography TEERequired MeasurementsAVA 0.9 cm2Peak Velocity 3.7 m/sAVA index Annulus Diameter 21 mmMean Gradient 35 mmHgEjection Fraction60%

Findings aortic valve calcificationModerate ARModerate to severe MRMild to moderate TRMild to moderate

55

55


Proposed 23mmSapien

Echocardiography

Coronary Angiography Coronary Angiography11/20/13Coronary Artery Disease SeverePrior revascularization (CABG or PCI) CABGAdditional Revascularization Indicated No

CT of Aortic Annulus 500 mm2

Aortic Annulus329 mm2

CTA : Distal aortaAortic bifurcationCommon iliacs

CTA : External iliac arteries

Peripheral Sizing CT AngioMinimal Luminal DiametersRightLeftCommon Iliac8 mmCommon Iliac8 mmExternal Iliac7 mmExternal Iliac7 mmCommon Femoral6-7 mmCommon Femoral6-7 mm

Procedural Plan Annulus Diameter MeasurementTHV Valve SizeProposedFemoral Access SideProposedSmallest Vessel Diameter Measurement21 TEE21x21 Gated CTA23 mm mm

Special Case ConcernsAccess

Videos for the TAVI procedure

Complications & Management Causes of hypotension after TAVIVascular complicationsiliac rupture

Ventricular rupture

Acute valve dysfunction

Coronary artery obstruction

Multiple rapid pacing episodes in pts with poor LV function

Suicidal LV in severe LVH [After removing AV obstruction LV decompresses to such an extent that the subvalvular hypertrophy obstructs outflow] treated with fluids & avoiding diureticsJ. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management Significant annular ruptureVentricular perforationPericardial drainage, auto-transfusion Conversion to open surgical closureDevice malposition

Device embolizationOverlapping valve in valve

Urgent endovascular/ surgical managementMajor ischemic stroke

Minor ischemic stroke

Hemorrhagic strokeCatheter-based, mechanical embolic retrieval

Aspirin, anticoagulants

Anticoagulation reversal, coagulopathy correction

J. Am. Coll. Cardiol. 2012;59;1200-1254

Complications & Management Atrial fibrillationRate control/ rhythm control via pharmacological or electrical cardioversionShock, low cardiac outputMajor bleedingVascular complicationsCareful systemic pressure management, inotropic support, IABP, or CPBHemodynamic support, blood transfusionUrgent endovascular repair/surgery

J. Am. Coll. Cardiol. 2012;59;1200-1254

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Case # 3RM is 88 years old Male with severe symptomatic AS NYHA 4BSA 1.75 Cr 1.22 Hb 11.5 PLT 181

High risk due to followingCAD (CABG x2 & multiple PCIs)MRCA prostate69STS 12EuroScore II 5.94Procedure NameIsolated AVReplRisk of Mortality11.994%Morbidity or Mortality39.912%Long Length of Stay20.333%Short Length of Stay8.877%Permanent Stroke3.041%Prolonged Ventilation32.088%DSW Infection0.447%Renal Failure12.706%Reoperation12.550%

Echocardiography TEE performedRequired MeasurementsAVA 0.7 cm2Peak Velocity 3.3 m/sAVA index Annulus Diameter 20 mmMean Gradient 30 mmHgEjection Fraction45%

Findings aortic valve calcificationModerate ARMild MRModerate TRMild

70

70


Proposed 26 mmSapien

Echocardiography

Coronary Angiography Coronary Angiography1/29/14Coronary Artery Disease SeverePrior revascularization (CABG or PCI) Multiple CABG & PCIsAdditional Revascularization Indicated Ostial LAD SVG

Coronary Angiography

Ostial SVG to LAD stenosis

CT of Aortic Annulus 500 mm2

CT 3D329 mm2

CTA : Distal aortaAortic bifurcationCommon iliacs

CTA : External iliacs

CTA : CFA (Axial Views)

Peripheral Sizing CT AngioMinimal Luminal DiametersRightLeftCommon Iliac10 mmCommon Iliac8-9 mmExternal Iliac8 mmExternal Iliac8 mmCommon Femoral8 mmCommon Femoral7 mm

Procedural Plan Annulus Diameter MeasurementTHV Valve SizeProposedFemoral Access SideProposedSmallest Vessel Diameter Measurement20 TEE Gated CTA26 mm Right7 mm

Special Case ConcernsLAD-SVG stenosis

Videos for TAVI procedure

ConclusionEvolving field, may be used in lower risk patients, and bicuspid AoVWhat is the durability? .. role of TAVI in low-gradient AS?Which institutions should be qualified to perform TAVI?TAVI for prosthesis degeneration?

With refinement in procedures and newer improved hardware may become an attractive alternative to AVR, repeat procedure possible

However for Severe symptomatic AS with low risk for surgery, Surgical AVR remains the standard treatment

Thank You

TAVI procedure review with cases

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