Transcatheter aortic valve implantation (TAVI) has been developed as an alternative to surgical aortic valve replacement for high-risk patients. TAVI involves threading a collapsible valve through blood vessels and implanting it to replace the diseased valve. Over 30,000 high-risk patients with severe aortic stenosis have undergone TAVI, based on evidence from studies showing it is safer than surgery for this group. TAVI indications may expand as longer-term data on outcomes becomes available and the procedure requires a multidisciplinary team approach and dedicated training.
3. Severe symptomatic aortic stenosis carries a poor
prognosis.
Surgical aortic valve replacement has been the standard of
care in adults with severe symptomatic AS.
The risks associated with surgical aortic valve replacement
are increased in: (High Risk Population)
Elderly patients: + Following Co Morbidity
Severe systolic heart failure
CVD
CAD
PVD
CKD
Ch respiratory dysfunction.
6. TAVI
• More than 30,000 patients with severe
symptomatic aortic stenosis considered
high risk for surgery have undergone the
treatment.
• This technique is still in its early stages, but
rapidly growing evidence has been developed
through observational studies, national and
device-specific registries,and
randomized clinical trials.
7. Indication:
Currently, there are no established indications or
guidelines for TAVR in the United States. Indications
are based on following trial and consensus.
PARTNER Trial - Transcatheter aortic-valve
implantation for aortic stenosis in patients who
cannot undergo surgery. N Engl J Med. 2010 Oct 21.
363(17):1597-607.
ACCF/AATS/SCAI/STS expert consensus
document on transcatheter aortic valve
replacement. J Am Coll Cardiol. 2012 Mar 27.
59(13):1200-54.
8. Indication No 1:
Patients with calcific aortic valve stenosis with the
following echocardiographic criteria:
Mean gradient greater than 40 mm Hg or jet
velocity more than 4 m/s and an initial aortic valve
area (AVA) of less than 0.8 cm 2 or indexed effective
orifice area (EOA) of less than 0.5 cm 2/m 2;
Qualifying AVA baseline measurement must be
within 45 days of the date of the procedure
9. Indication No 2:
One cardiac interventionalist and 2
experienced cardiothoracic surgeons agree that
medical factors either preclude operation or are
high risk for surgical aortic valve replacement,
based on a conclusion that the probability of death
or serious irreversible morbidity exceeds the
probability of meaningful improvement.
The surgeons' consult notes shall specify the
medical or anatomic factors leading to that
conclusion and include a printout of the calculation
of the Society of Thoracic Surgeons (STS) score to
additionally identify the risks in the patient; at least
1 of the cardiac surgeon assessors must have
physically evaluated the patient
10. Indication No 3:
Patient is deemed to have symptomatic
aortic valve stenosis, as differentiated from
symptoms related to comorbid conditions and
as demonstrated by New York Heart
Association (NYHA) functional class II or
greater.
11. In the European Union, Transcatheter Aortic
Valve Implantation is performed in patients
with severe aortic stenosis who are high-risk
surgical candidates with a logistic EuroScore of
more than 20% and in patients who have a
contraindication to surgical aortic valve
replacement.
12.
13. Contraindications and exclusion
criteria for TAVI are as follows:
Evidence of an acute MI at 1 month or less
before the intended treatment (defined as Q-wave
MI, or non–Q-wave MI with CK-MB twice normal in
the presence of MB elevation and/or troponin level
elevation [WHO definition].
14. Contraindications….
Aortic valve is a congenital unicuspid or congenital
bicuspid valve or is noncalcified.
Mixed aortic valve disease ( AS+ AR) with
predominant AR (>3+).
Hemodynamic or respiratory instability requiring
inotropic support, mechanical ventilation, or
mechanical heart assistance within 30 days of
screening evaluation.
15. Contraindications….
Need for emergency surgery for any reason
HOCM with or without obstruction.
Severe left ventricular dysfunction with LVEF of
less than 20%.
Severe pulmonary hypertension RV dysfunction.
Echocardiographic evidence of intracardiac mass,
thrombus, or vegetation.
16. Contraindications…
A known contraindication or hypersensitivity
to all anticoagulation regimens or an inability
to undergo anticoagulation for the study
procedure.
Native aortic annulus smaller than 18 mm or
larger than 25 mm as measured with echo.
MRI-confirmed stroke or TIA within 6 months
(180 days) of the procedure.
17. Contraindications…
Estimated life expectancy of less than 12
months due to noncardiac comorbid
conditions.
Severe incapacitating dementia.
Severe MR.
Renal insufficiency (creatinine level >3
mg/dL) and/or end-stage renal disease
requiring chronic dialysis at the time of
screening.
18. Contraindications:
Significant aortic disease, including abdominal
aortic or thoracic aortic aneurysm defined as a
maximal luminal diameter of 5 cm or greater,
marked tortuosity, atheroma or narrowing
(especially with calcification and surface
irregularities) of the abdominal or thoracic aorta.
Severe "unfolding" and tortuosity of the
thoracic aorta.
19.
20.
21. Aortic Regurgitation •AR is typically
paravalvular mild or
mild-moderate severity
•Most AR disappears
or reduces at 1 yr
follow-up.
23. (A) Left main coronary artery occlusion resulting from a bulky leaflet displaced over the
ostium.
(B) Successful percutaneous intervention restored left coronary
flow.
24. The principal transcatheter aortic valve implantation
devices currently in use:
(A) Edwards Sapien XT bioprosthesis and
(B) Medtronic CoreValve® bioprosthesis
26. Medtronic CoreValve
Penrose program was the
first CoreValve program in
CO, NM, UT, WY
Retrograde approach only
Equine Pericardium Leaflets
Nitinol Self-Expanding
Annular and Supra-coronary
fixation
18fr delivery system
Offers a 31mm valve size
29. Conclusion….
• Catheter based treatment of aortic stenosis is
improving.
• Restenosis after valvuloplasty has been overcome
after development of TAVI.
• Indications for TAVI can be expanded after the
availability of follow up of patients of the cohort.
• Team approach is essential for successful procedure.
• Training required for performance of TAVI and
dedicated imaging instruments.
• Patient selection is complex.