TAVI

Dr Vijay Amaranath,DMNIMS,Hyderabad.

Bird’s Eye View

Review the concept of TAVI Evaluation of patients considered for TAVI Review of evidence Identify future applications

Introduction

Rising life expectancy results in an increase of degenerative aortic stenosis

most frequent acquired heart valve disease and if untreated is associated with high mortality.

Operative Mortality for AVRSTS2001

(%)

UKCSR 1999-2001 (%)

EHS 2001

(%)

AVR3.7 3.1 2.7

AVR + CABG 6.3 7 4.3

AVR in octogenarians• 220 pts • Op mortality 13% if AVR• Op mortality 24% if AVR + CABG• Morbidity 60%• Survival 85%, 80%, 73% (1,3,5 yrs)

Benefits of AVR in octogenarians• 81% no/mild disability for daily

activities• 93% feel less disabled• 93% reassured to have access to

treatment despite their age

Eur J Cardio Thorac Surg 2007;31:600-606. Eur J Cardio Thorac Surg 2007;31: 1099-1105. Euro J Cardiothorac Surg 2006; 30: 722-727

Severe AS* - Percent of Patients Treated

J Heart Valve Dis2006;15:312-321; Circulation 2005;J Heart Valve Dis2006;15:312-321; Circulation 2005; European Heart Journal 2003;24:1231-1243;European Heart Journal 2003;24:1231-1243; Heart 1999;82:143-148Heart 1999;82:143-148

Many patients are not surgically treated!

Transcatheter Aortic Valve Implantation (TAVI)

• 1993: Andersen– First description of valve sutured in

stent– Animal model– Encountered major limitations

• Obstruction of coronary ostia

First human implantation: Alain Cribier First human implantation: Alain Cribier April 16, 2002 ( France)April 16, 2002 ( France)

Bovine pericardium valve23mm in diameter

balloon-expandable valves

first generation : Cribier-Edwards valve

Second generation Edwards SAPIEN THV

bovine pericardium that is firmly mounted within a tubular, slotted, stainless steel balloon-expandable stent

‘Sapien’ device • Balloon deployment• Transapical

deployment also• Leaflets in open

mode, more chance for AR

‘Sapien XT’ device • Fewer rows and columns• Shorter stent size• More radial strength grater

durability• More closed form, less

chance for AR

CoreValve Revalving device

first implantation in 2005 - Grube et al• first-generation : bovine pericardial tissue and

was constrained with 25F delivery catheter. • second-generation : porcine pericardial tissue

within a 21 F catheter .

multi-level self-expanding Nitinol frame• upper third - low radial force : sits prosthesis

in the aortic root• middle third - high hoop strength ,valve

leaflets are attached ,avoid impinging the coronaries.

• lower third - high radial force and sits within the left ventricular outflow tract.

Procedure & Hardware

Indications

Logistic EuroSCORE >20% or STS Score > 10.Logistic EuroSCORE >20% or STS Score > 10.

Work upRole of imaging in pre-procedural and post procedural assessment

oversizing relative to the aortic annulus (I)Anchoring to prevent migration(II) sealing to prevent paravalvular aortic regurgitation(III)proper valve functioning to prevent patient-prosthesis mismatch

Patient Evaluation• CT Angiogram

– Arterial calcification– Arterial tortuosity– Minimal luminal diameter

• Vascular access– Sites

• Transfemoral• Transapical

– Left ant. thoracotomy– More direct, shorter catheter– Septal hypertrophy– Ascendra2, Sapien valve

• Transaortic – Upper partial sternotomy– Mini-sternotomy 2/3 RICS– Aorta 5 cm above valve– Less painful, familiar approach– Manipulation of ascending aorta

• Subclavian

Percutaneous or Cut-down technique

Percutaneous or Cut-down technique

Approaches

BAV• Balloon aortic valvuloplasty: 20x30

mm (for # 23) or 23x30 mm (for # 26)

• Appropriate angiographic projection in line with the plane of annulus [LAO200/Cran200]

• midpoint of balloon at the annular level PACE INFLATE CHECK DEFLATE stop pacing

Transfemoral Approach Sapien ValveTransfemoral Approach Sapien Valve

41

RetroFlex 3 introducer Sheath Set

Edwards SAPIEN THV

RetroFlex 3 Delivery System

RetroFlex Balloon Catheter

AtrionInflation Device

RetroFlex Dilator KitCrimper

Hardware

CrimperDilator set Inflation device

Hardware

Transfemoral ApproachValve Deployment

Aortic Pressure

RV pacing: 200/min

Edwards SAPIEN implantation

Edwards SAPIEN implantation

AscendraAscendra™™ Transapical Approach Transapical Approach

47

Edwards SAPIEN™ THV

Ascendra™ Introducer Sheath Set

Ascendra™ Delivery System

Crimper

Atrion Inflation Device

Ascendra™ Valvuloplasy Catheter

Transapical Approach

Direct left ventricular puncture

Transapical Approach

Placement and valve deployment

Transapical Approach

three stages of CoreValve deployment.

transfemoral approach

Subclavian approach

closure device such as Prostar XLTM(Abbott

Occlusive iliac dissection

Iliac artery rupture…

…repaired with a covered stent

lung injury, pneumothorax, or pleural bleeding

respiratory compromise and prolonged

ventilation

cardiac tamponade

Transapical Approach

Complications & Management

Causes of hypotension after TAVI•Vascular complications—iliac 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 diuretics

•Vascular complications—iliac 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 diuretics

Coronary obstruction

• Displacing an unusually bulky, calcified native leaflet over a coronary ostium

• height of the coronary ostia, and dimensions of the sinus of Valsalva.

ostia should be minimally located 14 mm away from the leaflets insertion.

Complications & Management

Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve.Treated with CPB device explantation AVRAlso PCI/CABG

Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve.Treated with CPB device explantation AVRAlso PCI/CABG

(A) Left main coronary artery occlusion resulting from a bulky leaflet displaced over the ostium. (B) Successful percutaneous intervention restored left coronaryflow.

Mitral valve injury

• transvenous, transseptal approach

• antegrade apical approach : avulsion of a mitral chordae

• ventricular end of a transcatheter prosthesis can be expected to contact the anterior mitral curtain

Complications & Management

Significant annular ruptureVentricular perforationSignificant annular ruptureVentricular perforation

•Pericardial drainage, auto-transfusion •Conversion to open surgical closure•Pericardial drainage, auto-transfusion •Conversion to open surgical closure

Device malposition

Device embolization

Device malposition

Device embolization

Overlapping ‘valve in valve’

Urgent endovascular/ surgical management

Overlapping ‘valve in valve’

Urgent endovascular/ surgical management

Major ischemic stroke

Minor ischemic stroke

Hemorrhagic stroke

Major ischemic stroke

Minor ischemic stroke

Hemorrhagic stroke

Catheter-based, mechanical embolic protection

Aspirin, anticoagulants

Anticoagulation reversal, coagulopathy correction

Catheter-based, mechanical embolic protection

Aspirin, anticoagulants

Anticoagulation reversal, coagulopathy correction

Stroke

• atheroembolism • Calcific embolism from the aortic valve• air embolism ; prolonged hypotension, and

dissection of arch vessels

Embolic protection device

Heart block

• 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 LVOT

• Occurrence of CHB/LBBB– BAV 46%– Balloon/prosthesis positioning &wire-crossing of the aortic valve 25%– Prosthesis expansion 29%.

• Pre-existing RBBB risk factor for CHB

• 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 LVOT

• Occurrence of CHB/LBBB– BAV 46%– Balloon/prosthesis positioning &wire-crossing of the aortic valve 25%– Prosthesis expansion 29%.

• Pre-existing RBBB risk factor for CHB

Complications & Management Aortic Regurgitation

•Typically paravalvular mild or mild-moderate severity•Most of AR disappears or reduces at 1 yr follow-up [13% absent, 80% mild AR]

•Typically paravalvular mild or mild-moderate severity•Most of AR disappears or reduces at 1 yr follow-up [13% absent, 80% mild AR]

Complications & Management

Paravalvular AR

Central valvular AR

Paravalvular AR

Central valvular AR

Post-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’

Post-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’

• Acute renal failure - severe renal dysfunction and dialysis( 3 %) requirement might occur

• Arrhythmia- Atrial fibrillation or ventricular ectopy might be precipitated by cardiac manipulation

Medications post-TAVI

Aspirin for life and clopidogrel for 3 months

patient on anticoagulation Warfarin plus clopidogrel for 1 month post-

TAVI, followed by Warfarin plus Aspirin for 1 year and then continue Warfarin only.

ONGOING TRIALS

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves Trial

Edwards SAPIEN XTTM device and delivery systems: NovaFlex (transfemoral

access) and Ascendra2 (transapical access) in patients with symptomatic, calcific, severe aortic stenosis.

intermediate risk [ STS score of 4-8% ]

SURTAVI

• Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

intermediate risk [ STS score of 3-8% ]

Danish study

Irrespective of risk score randomized to TAVI vs SAVR

TAVI in Degenerated Bioprostheses

• Aortic– Capable with CoreValve and Sapien– Bioprosthesis only– Annular/Size diameter

• CoreValve: not in annulus < 21mm

• Mitral– Transapical approach– Sapien only

• Pulmonary

TAVI in a patient with a history of mitral valve replacement

Valve-in-valve

TAVI in both Stented and stentless bioprosthetic valve dysfunction

newly approved transapical devices

• What is the durability?• What is the role of TAVI in low-gradient AS?• Which institutions should be qualified to perform TAVI?• TAVI for prosthesis degeneration? • Will there be a use of catheter valve implantation in

lower risk population?

TAVI is currently the treatment of choice for patients considered not to be candidates for SAVR and proven alternative in high risk cases .

Thank You