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 AVR AVR in octogenarians STS2001 UKCSR EHS • 220 pts (%) 1999-2001 2001 • Op mortality 13% if AVR (%) (%) • Op mortality 24% if AVR + CABG AVR • Morbidity 60% 3.7 3.1 2.7 • Survival 85%, 80%, 73% (1,3,5 yrs) AVR + CABG 6.3 7 4.3 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 ageEur J Cardio Thorac Surg 2007;31:600-606. Eur J CardioThorac Surg 2007;31: 1099-1105. Euro J Cardiothorac Surg2006; 30: 722-727
Many patients are not surgically treated! Severe AS* - Percent of Patients TreatedJ Heart Valve Dis2006;15:312-321; Circulation 2005; European Heart Journal 2003;24:1231-1243; Heart 1999;82:143-148
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 April 16, 2002 ( France) Bovine pericardium valve 23mm 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• ‘Sapien XT’ device Balloon deployment • Fewer rows and columns• Transapical deployment also • Shorter stent size• Leaflets in open • More radial strength grater mode, more chance durability for AR • 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
IndicationsLogistic 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
• Vascular access – Sites • Transfemoral • Transapical – Left ant. thoracotomy – More direct, shorter catheter – Septal hypertrophy – Ascendra2, Sapien valve Percutaneous Percutaneous • Transaortic or Cut-down or Cut-down – Upper partial sternotomy technique technique – Mini-sternotomy 2/3 RICS – Aorta 5 cm above valve – Less painful, familiar approach – Manipulation of ascending aorta • Subclavian
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
Transapical ApproachPlacement and valvedeployment
three stages of CoreValve deployment.
closure device such as Prostar XLTM(Abbott
Occlusive iliac dissection
Iliac artery rupture…
…repaired with a covered stent
Transapical Approach lung injury, pneumothorax, or pleural bleeding respiratory compromise and prolonged ventilation cardiac tamponade
Complications & ManagementCauses of hypotension after TAVI ••Vascularcomplications—iliac rupture Vascular complications—iliac rupture ••Ventricularrupture Ventricular rupture ••Acutevalve dysfunction Acute valve dysfunction ••Coronaryartery obstruction Coronary artery obstruction ••Multiplerapid pacing episodes in pts with poor LV function Multiple rapid pacing episodes in pts with poor LV function ••‘Suicidal’LV in severe LVH [After removing AV obstruction LV ‘Suicidal’ LV in severe LVH [After removing AV obstruction LV decompresses to such an extent that the subvalvular hypertrophy decompresses to such an extent that the subvalvular hypertrophy obstructs outflow] treated with fluids & avoiding diuretics 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 Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve. calcified nodule from aortic valve. Treated with CPB device explantation AVR Treated with CPB device explantation AVR Also PCI/CABG Also PCI/CABG
(A) Left main coronary artery occlusion resulting from a bulky leaflet displaced overthe 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
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
Complications & Management Aortic Regurgitation ••Typicallyparavalvular mild or Typically paravalvular mild or mild-moderate severity mild-moderate severity ••Mostof AR disappears or reduces Most of AR disappears or reduces at 11yr follow-up [13% absent, 80% at yr follow-up [13% absent, 80% mild AR] mild AR]
Complications & ManagementParavalvular AR Paravalvular AR Post-deployment balloon dilation, rapid RV Post-deployment balloon dilation, rapid RV pacing for stabilization, ‘valve in valve’ pacing for stabilization, ‘valve in valve’ implantation implantationCentral valvular ARCentral valvular AR Usually self-limited, Gentle probing of leaflets Usually self-limited, Gentle probing of leaflets with aasoft wire or catheter with soft wire or catheter Delivery of aa2nd TAVR device, ‘valve in Delivery of 2nd TAVR device, ‘valve in valve’ 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-TAVIAspirin for life and clopidogrel for 3 monthspatient on anticoagulation Warfarin plus clopidogrel for 1 month post- TAVI, followed by Warfarin plus Aspirin for 1 year and then continue Warfarin only.
PARTNER II Trial: Placement ofAoRTic 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 .