Percutaneous Aortic Valve Replacement
without Predilatation for Symptomatic
Severe Aortic Stenosis in High-Risk
Patients
Lev G, Valdivieso L, Fava C, Caponi G, Hidalgo G,
Mendiz O.
Favaloro Foundation University Hospital. Buenos Aires.
Argentina.
www.fundacionfavaloro.org
CoreValve Primario
Background
Since the beginning of percutaneous
Aortic valve replacement was considered
that the previous balloon valvuloplasty
was essential to facilitate optimal
implant and expansion.
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CoreValve Primario
Background
The procedure has a certain risk of
stroke and valvuloplasty may have an
important responsibility.
The rapid pacing for valvuloplasty can
have deleterious effect mainly the pts
with ventricular dysfunction.
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Primary Aortic Valve Replacement
AIM
To assess the in-hospital and follow-up results
of the primary (without predilatation)
percutaneous aortic valve replacement with
the selfexpandable Nitinol CoreValve device
(Medtronic®), in patients with symptomatic
aortic valve severe stenosis and high surgery
risk.
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Primary Aortic Valve Replacement
Materials and Methods
• Between march 2009 and december 2011, 57
consecutive patients (ptes) with symtomatic
severe aortic valve stenosis were treated with
CoreValve device.
• 48 ptes (84%) with primary elective
implantation.
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Primary Aortic Valve Replacement
Material and Methods
Characteristic
n=48 ptes
Age (years)
79±8
Males (%)
30 (63)
Cardiovascular risk factors
27%
30%
21%
19%
13%
20%
10%
0%
Hypertension
Diabetes
Tabaquism
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Dyslipemia
Primary Aortic Valve Replacement
Material and Methods
Variable
n=48 ptes
Personal history
AMI (%)
10 (21)
CABG (%)
9 (19)
PTCA (%)
13 (27)
Chronic renal failure (%)
6 (13)
Severe COPD (%)
8 (17)
E.F.< 40% (%)
4 (8)
Stroke (%)
5 (10)
Logistic Euroscore
20±15
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Primary Aortic Valve Replacement
Material and Methods
Complementary Studies
Variable
n=48 ptes
ECG
Sinusal rythm (%)
43 (90)
Sinusal rythm+1º AVB (%)
1 (2)
Sinusal rhythm + RBBB (%)
1 (2)
Atrial fibrilation(%)
2 (4)
Pacemaker rythm (%)
1 (2)
Echo-Doppler
Mitral insufficiency grade 3-4 (%)
4 (8)
Aortic valve ring (mm)
22±3
Severe grade aortic valve calcification (%)
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30 (63)
Primary Aortic Valve Replacement
Results
• CoreValve´s primary implantation was
succesfully achieved in 48 ptes:
– Predilatation was requiered in 1 patient
because of extremely asymetric valve
expansion.
– Postdilatation was necessary in 15 ptes
(31%).
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Primary Aortic Valve Replacement
30 days Results
Variable
n=48
Procedure succeed (%)
46 (96)
MACE (%)
2 (4)
Death (%)
2 (4)
Cardiac failure(%)
15 (31)
Minor Stroke(%)
1 (2)
Right ventricle perforation treated with pericardiocentesis (%) 3 (6)
Acute renal failure (%)
2 (4)
Permanent pacemaker (%)
13 (27)
AV Complete block (%)
10 (21)
Left bundle branck block (%)
17 (35)
Final moderate aortic valve insuficiency(%)
20 (42)
Final mild aortic valve insuficiency(%)
27 (56)
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Primary Aortic Valve Replacement
Follow-up Results
Variable
n=46
Follow-up period (2-35 months)
12±11
Death of any cause (%)
5 (11)
AMI(%)
1(2)
Minor Stroke (%)
1 (2)
Permanent pacemaker (%)
1 (2)
Asymtomatics (%)
39 (85)
Echo-Doppler
n=41
Well-function valve(%)
41 (100)
Mild aortic valve insufficiency (%)
30 (73)
Moderate aortic valve insufficiency (%)
11 (27)
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Primary Aortic Valve Replacement
Conclusión
The percutaneous aortic valve
replacement without predilatation with
the self expandable Nitinol device was
safe and efective with low Stroke
incidence.
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