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