Download Transcatheter Aortic Valve Implantation (TAVI/R) for Severe Aortic

Transcatheter Aortic Valve
Implantation (TAVI/R) for
Severe Aortic Stenosis
Dr Dylan G Wynne
PhD, BSc (Hons), MBBS, FRACP
Consultant Interventional Cardiologist
0562/SAH/1112/SAH
Transcatheter Aortic Valve Implantation
Overview
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Introduction
TAVI historical perspective
Pre-procedural assessment
Review of evidence
Complications & Management
Indications and Current Guidelines
Limitations and future directions
Conclusions
Clinical Course of Severe Aortic Stenosis
• Causes
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Degenerative
Congenital – mainly bicuspid
Rheumatic
Others – less common
(including supra-aortic,
subaortic)
Open AVR – Mechanical and Bioprosthetic
• Excellent operation
• Surgical Risk 1 – 3%
• Mechanical valve
– Permanent need for
anticoagulation with Warfarin
• Bioprosthetic Valve
– Valve degeneration over time
– TAVI valve in valve an option
• Growing Elderly surgically
prohibitive population.
The Majority of AS Patients Indicated
Per Guidelines Remain Untreated
Dr. Alain Cribier
First-in-Man PIONEER
• Percutaneous Transcatheter
Implantation of an Aortic Valve
Prosthesis for Calcific Aortic Stenosis
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First Human Case Description
Alain Cribier, MD; Helene Eltchaninoff, MD; Assaf Bash, PhD;
Nicolas Borenstein, MD; Christophe Tron, MD; Fabrice Bauer,
MD; Genevieve Derumeaux, MD; Frederic Anselme, MD;
François Laborde, MD; Martin B. Leon, MD
Conclusions – “Nonsurgical implantation of a prosthetic
heart valve can be successfully achieved with immediate
and midterm hemodynamic and clinical improvement.”
April 16, 2002
TAVR: Where are we today ?
A considerable worldwide expansion
with huge potential
200 000 TAVR performed over 10 years
Success based on innumerable registries and
evidence based trials
Evolution of TAVI
European Cumulative Implants
Australian Experience
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Began 2008
18 (10) Centres. (Mostly NSW / VICT)
2100 total implants.
Edwards, CoreValve, Lotus, Portico
Academic breeding ground
– New technologies
– International Clinical Trial Involvement
• Economic restraints of Conservative
Health Care – last health care to get
technology approved.
Cine of Edwards case.
CoreValve aortic valve replacement
Balloon valvuloplasty
0562/SAH/1112/SAH
CoreValve aortic valve replacement
Balloon valvuloplasty
0562/SAH/1112/SAH
CoreValve aortic valve replacement
Balloon valvuloplasty
Partial deployment
0562/SAH/1112/SAH
CoreValve aortic valve replacement
Balloon valvuloplasty
Partial deployment
Full deployment
0562/SAH/1112/SAH
Tests Required + Pre-Procedure Assessment
• TTE / TOE
– Determine accurate annulus sizing
– 3D TOE for annular sizing if CT
prohibitive due to renal impairment
• DSE in those with low EF / low
gradient AS
• Cardiac catheterization within past
6 months
• Pulmonary function tests
• Carotid duplex
• Frailty assessment
CT Assessment
• Evaluate the ascending Aorta
for calcification
• Evaluate the femoral and iliac
arteries for calcification
• Annulus area determination
Anatomical Contraindications
Calcified +
Tortuous ++
Diameter < 6.0 mm
Calcifications +
Tortuosities less control++
Multiple Access Sites
THE EVIDENCE
0562/SAH/1112/SAH
PARTNER 5-year FU in Lancet (March, 2015)
Five-Year Outcomes after
Randomization to Transcatheter or
Surgical Aortic Valve Replacement:
Final Results of The PARTNER 1 Trial
CoreValve US Pivotal
Trial 48 month F/U
A Randomized Comparison of
Self-expanding Transcatheter and
Surgical Aortic Valve Replacement
in Patients with Severe Aortic
Stenosis Deemed at Increased
Risk for Surgery 2-Year Outcomes
Complications & Management
• Aorto / Iliac rupture
• Conduction Disturbances
• Annular Rupture
• Device Embolization
• Ventricular Rupture
• Valve in Valve Malposition
• Coronary Ostia Occlusion
• AR and PVL
• Stroke
(Need for Surgical Bailout)
Associated with Increase Mortality
Coronary Occlusion
Left main stem compromise with semi-occlusive displacement of calcified
nodule from aortic valve.
Treated with CPB device explantation  AVR
Also PCI/CABG
Cardiol Clin 29 (2011) 211–222
J. Am. Coll. Cardiol. 2012;59;1200-1254
Risk of ischaemic and bleeding
complication after TAVI
(<30days Post TAVI)
Stroke post TAVI
• Clinical stroke after TAVI: 2.7-6.7%
– Increased risk of mortality 3x
– Causes significant morbidity
– 50% of stroke perioperative
• Mechanisms:
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Athero-calcific embolism
Thromboembolism
Air embolism
Valve thrombosis
• Silent Brain Infarction common : 58100%
• Predictors of early CVE
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Pre + post dilatation
Procedural duration
Valve repositioning
Hx of stroke
• Use of embolic protection devices.
• New onset Atrial Fibrillation
Thromboembolic recommendations
Post Procedure Aortic Regurgitation
 Inaccurate deployment:
too high/low
 Asymmetric
calcification/annulus
 Undersized device
 Central: overdilated,
leaflet injury
Increased Mortality with Mod / Severe AR
Moderate to Severe AR
• Balloon Valve Dilatation
• Percutaneous Closure
• Valve in Valve
Complete Heart Block and PPM Requirement
• 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 &wirecrossing of the aortic valve 25%
– Prosthesis expansion 29%.
• Pre-existing RBBB risk factor for CHB
J. Am. Coll. Cardiol. 2012;59;1200-1254
Clinical Indications
• A 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
Special Indications
Bicuspid Aortic Valve
TAVI within failed Bioprosthetic AVR
Valve-in-valve procedures. A, A 26-mm CoreValve device
(Medtronic) implanted inside a 25-mm Mitroflow valve
(Sorin). B, A 23-mm Edwards SAPIEN (Edwards
Lifesciences) implanted inside a 23-mm CarpentierEdwards porcine valve (Edwards Lifesciences).
TAVI – Limitations of 1st Generation Devices
Remaining Challenges and hopes for New Generation Devices
Vascular access
Smaller systems, dilatable sheaths
Ease/certainty of deployment
Novoflex, Accutrak delivery systems
Aortic regurgitation
Novel designs, larger devices
Atheroembolic stroke
Distal protection devices
Need for pacemaker implantation
Accurate placement
Cost
Reimbursement pending for Australia
0562/SAH/1112/SAH
CE Mark Evolution
Lotus Valve System - Advantages
• Controlled mechanical expansion
enables precise positioning
• Central radiopaque marker to aid
precise positioning
• Functions early, enabling
hemodynamic stability
• Fully repositionable and
retrievable
• Adaptive seal designed to
minimize paravalvular leak
LOTUS Valve : Reprise II
Clinical Trial
• 120 patients > 70 yrs
• STS score > 8% or deemed
surgical high risk
• Severe AS
• Results
• Access, delivery, deployment,
system retrieval 100%.
• Mean Aortic gradient – 46 to 11
mmHg
• AVA 0.7 to 1.7 cm2
• Device success – Absence of
mortality - 99.2%.
• Valve embolization / migration /
malpositioning - 0%
• PPM rate remains high >25%.
Guidelines (AHA/ACC/ECC 2012)
• TAVI is accepted as a treatment option.
• TAVI is indicated in pts. with symptomatic
AS who are not suitable for AVR as
assessed by a heart team (IB).Prerequisite:
Improvement in quality of life is likely and
life expectancy is > 1 year considering
comorbidities.
• Both, TAVI and AVR should be considered
in surgical high risk patients with severe
symptomatic AS (IIaB): No formal
differential indication between TAVI and
AVR. Decision by a heart team after careful
consideration of the individual risk profile
and anatomic suitability.
Current TAVI Guidelines
ESC/EACTS-GL 2012 Vahanian A et al Eur Heart J 2012;33:2451-96
Complexity of the Multidisciplinary Team
The Severe AS-TAVI Population
Old…very old…
• Frail…very frail
• Lots of co-morbidities…
• Prior CABG (poor LV
function)
• CKD
• Severe COPD
• PVD
• Chronic AF
• Cancer in remission
Favour TAVI for SAVR
• Porcelain aorta
• Hostile chest – Cobalt / mantle
radiation
• Liver disease / cirrhosis
– MELD score < 8 – SAVR
– MELD 8-20 – awake TAVI
– > 20 palliation (BAV)
• LIMA or RIMA across midline
• Age > 90 years
• More than 2 prior sternotomies
• Severe lung disease(FEV1 <40%
and FEV1 , 800mls
• Redo AVR – TAVI if > 23 prior
prosthesis.
• ESRF – TAVI / Med Mx
• Moderate Dementia
• Frailty / debility / immobility
Patient Selection
Frailty Testing
Select patients destined to
die of Severe Aortic Stenosis
rather than with AS
Not currently
Indicated
Outstanding Issues of Cost Effectiveness and Reimbursement
TAVI - CONCLUSIONS
• Rigorous Evidence Based Research
– Proven superiority to medical management in inoperable severe AS.
– Equivalent to SAVR in high surgical risk patients.
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Strict Guidelines – Heart team and onsite Cardiothoracic Surgery
Proven safety and efficacy. Cost effectiveness and Reimbursement?
Move to intermediate risk populations.
Improvements in prevention of Stroke, need for pacemaker, and PV leak
will continue to develop.
• Valve durability confirmed to five years and beyond? IBE / Thrombosis?
• Aspects for frailty and futility are still to be determined
Thank You.
http://www.peninsulacardio.com.au/
Tel : 02 9971 7668