transcatheter aortic valve intervention 3 rd april 2012 dr nithin p g dr. nithin p g
TRANSCRIPT
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Dr. Nithin P G
Transcatheter Aortic Valve Intervention
3rd April 2012
Dr Nithin P G
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Dr. Nithin P G
Overview
• Introduction
• Procedure– Indications & Pre-procedural work up – Procedure & Hardware – Post-op care, Complications & Management– Review of evidence
• Conclusions
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Dr. Nithin P G
Introduction
AVR
High risk for surgery
Complications
30-40% do not undergo Sx•Advanced age•LV dysfunction•Multiple co-morbidities•Pt. preference•Physician assessment
“Symptomatic Severe Aortic Stenosis” Prohibitive risk
Inoperability
•~3% mortality (STS, EuroSCORE)•~2% Stroke•~11% prolonged ventilation•Organ failure•Thromboembolic Complications•Bleeding•Prosthetic valve Dysfunction
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Introduction
Alternatives
• Balloon Aortic Valvuloplasty– Palliation – Bridge to AVR
• Medical management
• TAVI
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Dr. Nithin P G
Transcatheter Aortic Valve Intervention
Indications & Pre-procedural work up
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Dr. Nithin P G
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
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Dr. Nithin P G
Indications
Patient selection in clinical trials
Logistic EuroSCORE >20% or STS Score > 10.
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Indications
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Requisites
• ‘Heart team’ approach– Specific team leader– Close communication– ‘Preplanning procedure’
• Large cathlabs/ ‘hybrid’ rooms– Fluoroscopic imaging– TEE capabilities– GA/ CPB– Vascular intervention – Urgent AVR, CABG, Vascular
complications
• Anesthesia– Conscious sedation/ GA– CPB facility– Hemodynamic monitoring
and management
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Dr. Nithin P G
Work up
• Pre-anesthetic work up
• Cardiothoracic evaluation [access, AVR, risk assessment]
• Imaging– AS severity, morphology, calcification, annular size and shape– Aortic root, annulus to coronary ostia (>8mm), Atheroma burden,
calcification– Other valvular disease, sub aortic obstruction– LV function– Vascular anatomy from access site to annulus– Cerebro vascular imaging
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Dr. Nithin P G
Work up
Role of imaging in pre-procedural and post procedural assessment
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Transcatheter Aortic Valve Intervention
Procedure & Hardware
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Dr. Nithin P G
Procedure & Hardware
• LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg / MAP >75 mm Hg]
• 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
J. Am. Coll. Cardiol. 2012;59;1200-1254Modified from www.edwards.comwww.edwards.com
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Dr. Nithin P G
Procedure & Hardware
• Pacing leads – Trans venous or epicardial• Anticoagulation
– Large sheaths – Heparin [ACT>300]
• Intra-procedural TEE– Guidewire placement– Valve placement
• Stable position• No coronary obstruction• No interference with mitral valve function• No conduction system impingement• No overhanging native aortic leaflets• Avoidance of aortic root complications (rupture & dissection)
– Post deployment assessment [MR, AR]
TEE- Mid esophageal long axis view
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Procedure & Hardware
Balloon Aortic Valvotomy• Prepping and draping Anesthesia Diagnostic arterial access: C/L FA
access with 6F sheath pigtail catheter for C/L iliofemoral angiography, location of puncture marked
• Femoral vein access: I/L to diagnostic access with 7F sheath, for RHC and pacing leads
• Therapeutic arterial access: Percutaneous puncture/surgical preparation standard diagnostic J 0.035 Guidewire +14F long (24 cm) sheath, heparin
• Valve crossing: AL1 into ascending aorta exchanged with straight tip 0.035 Guidewire to cross AV AL1 into LV & wire exchanged with Amplatz extrastiff 0.035, 260 cm length Guidewire
BAV Valve implantation
MMCTS.2007.003077
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Dr. Nithin P G
Procedure & Hardware
• 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
• Balloon aortic valvuloplasty videoMMCTS.2007.003077
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Dr. Nithin P G
Procedure & Hardware‘Sapien XT’ device ‘CoreValve’ device
Self expandable Nitinol frame
Porcine Pericardial Tissue
European Heart Journal (2011) 32, 140–147
Cardiol Clin 29 (2011) 211–222
•Superior hemodynamics•Lower risk for PPM
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Dr. Nithin P G
Procedure & Hardware
CrimperDilator set Inflation device
www.edwards.com
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Dr. Nithin P G
Procedure & Hardware
•‘Sapien’ Deployment video
•‘Sapien XT’ video
•‘CoreValve’ Deployment video
www.edwards.com
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Dr. Nithin P G
Procedure & Hardware
Pressure tracings before and after TAVR
European Heart Journal (2011) 32, 140–147
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Dr. Nithin P G
Procedure & Hardware
‘Sapien’ device • Balloon deployment• Transapical
deployment also• Leaflets in open
mode, more chance for AR
‘CoreValve’ device• Partially repositionable• Larger annular size• Higher chance for CHB
‘Sapien XT’ device • Lesser calcification
[reduction of 98% calcium binding sites]
• Shorter stent size• More radial strength grater
durability• More closed form, less
chance for AR
www.edwards.com www.medtronic.com
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Dr. Nithin P G
Procedure & Hardware
European Heart Journal (2011) 32, 140–147
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Dr. Nithin P G
Procedure & Hardware
Device success
– Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system
– Correct position of the device in the proper anatomical location
– Intended 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 location
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Transcatheter Aortic Valve Intervention
Post-op care, Complications & Mx
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Dr. Nithin P G
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, DAPT
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Complications & Management
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Dr. Nithin P G
Complications & Management
Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve.Treated with CPB device explantation AVRAlso PCI/CABG
Cardiol Clin 29 (2011) 211–222J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
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 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
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
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]
J. Am. Coll. Cardiol. 2012;59;1200-1254Cardiol Clin 29 (2011) 211–222
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Dr. Nithin P G
Complications & Management
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’
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Complications & Management Rapid Pacing for stabilization
‘Valve in Valve’ Implantation
Reduction of diastole
Cardiol Clin 29 (2011) 211–222
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Dr. Nithin P G
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
Cardiol Clin 29 (2011) 211–222J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Complications & Management
Significant annular ruptureVentricular perforation
•Pericardial drainage, auto-transfusion •Conversion to open surgical closure
Device malposition
Device embolization
Overlapping ‘valve in valve’
Urgent endovascular/ surgical management
Major ischemic stroke
Minor ischemic stroke
Hemorrhagic stroke
Catheter-based, mechanical embolic retrieval
Aspirin, anticoagulants
Anticoagulation reversal, coagulopathy correction
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Complications & Management
Atrial fibrillationRate control/ rhythm control via pharmacological or electrical cardioversion
Shock, low cardiac outputMajor bleedingVascular complications
•Careful systemic pressure management, inotropic support, IABP, or CPB•Hemodynamic support, blood transfusion•Urgent endovascular repair/surgery
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Transcatheter Aortic Valve Intervention
Review of evidence
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Dr. Nithin P G
Review of Evidence
Registry data
•Age> 80 years
•EuroSCORE [> 23 ‘Sapien’, >16 ‘CoreValve’]
•Route of implantation no difference in procedural success rate b/w TF & TA accesses
•Major bleeding more in TA vs. more vascular complications in TF
J. Am. Coll. Cardiol. 2012;59;1200-1254
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Dr. Nithin P G
Review of EvidencePARTNER Trial Design
Cohort A84 yrsN=699
Cohort B83 yrsN=358
J. Am. Coll. Cardiol. 2012;59;1200-1254www.nejm.org
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Dr. Nithin P G
Conclusion
• Evolving field, may be used in lower risk patients, bicuspid AoV
• ‘Criteria to screen eligible patients’ dynamic
• 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, AVR Sx remains the standard treatment
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Dr. Nithin P G
Thank You
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Dr. Nithin P G
MCQ’s
1. Which of the following is not a contraindication for TAVI?
a) Expected survival >12 months
b) Severe PAH
c) Severe aortic disease
d) LVEF<20%
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Dr. Nithin P G
MCQ’s
2. Best investigation for planning the precise coaxial alignment of the stent-valve along the centerline of the aortic valve and aortic root
a) TEE
b) Angiography
c) CMR
d) MDCT
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Dr. Nithin P G
MCQ’s
3. Preferred access route in case of septal hypertrophy?
a) Transfemoral
b) Transapical
c) Transaortic
d) Subclavian
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Dr. Nithin P G
MCQ’s
4. TAVR using ‘CoreValve’ device is not done via
a) Transfemoral
b) Transapical
c) Transaortic
d) Subclavian
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Dr. Nithin P G
MCQ’s
5. Advantages of Sapien XT include all except-
a) Lesser calcification
b) Longer stent size
c) More radial strength
d) Lesser risk for AR
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Dr. Nithin P G
MCQ’s
6. ‘Device success’ is not achieved if
a) AVA =1.2 cm2
b) mean AV gradient= 30 mm Hg
c) peak velocity =2.75 m/s
d) mild prosthetic valve AR
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Dr. Nithin P G
MCQ’s
7. Patient undergoes transfemoral TAVI with ‘Sapien’ valve, immediate post procedure angio noticed to have moderate AR, SBP-100 mm Hg; first response would be
a) Rapid RV Pacing
b) Gentle probing with catheter
c) Prepare for urgent AVR
d) IABP
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Dr. Nithin P G
MCQ’s
8. Patient undergoes successful transfemoral TAVR with ‘CoreValve’ device, immediate post procedure angio & TTE good device position and function, after sheath removal and shifting to ICU pt goes into shock, most likely cause
a) RV pacing induced VF
b) Vascular complications
c) Device malposition
d) Moderate AR
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Dr. Nithin P G
MCQ’s
9. For TAVR optimum annulus to coronary artery distance should be
a) >4mm
b) >5mm
c) >8mm
d) >10mm
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Dr. Nithin P G
MCQ’s
10. After uncomplicated TAVR routine post-op care and discharge advice does not include
a) Early extubation and ambulation
b) Control of Post-op hypertension
c) Pre-discharge TTE
d) OAC
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Dr. Nithin P G
MCQ’s
11. Which is false regarding TAVI
a) PPM is less likely compared to surgical bioprosthesis
b) ‘Valve in valve’ implantation is an acceptable option in patients with high risk for surgical AVR and post procedural moderate AR
c) AR after TAVR is usually paravalvular
d) Patients with post procedural AR at 1 year follow up 90% of pts show a gradual increase in severity